Z-2603-2019Class I

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use

Name: Z-2603-2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
Creator: Medtronic Vascular
Published: 2019-03-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-03-15 / Terminated / root cause: design

FDA source

Medtronic Vascular began a recall of SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use on 2019-03-15. FDA classified it as Class I and gives the reason as "There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2603-2019
Classification: Class I
Status: Terminated
Initiated: 2019-03-15
Posted: 2019-10-01
Terminated: 2024-04-26
Recalling firm: Medtronic, Inc.
Product: SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
Product code: DQY Catheter, Percutaneous
Reason for recall: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Root cause tag: design
FDA root cause: Component design/selection
Action: Medtronic initiated immediate communications to consignees on 15-Mar-2019. Consignees were asked to quarantine and/or return unused affected product, and confirmation of the immediate notification was requested per local requirements. In the US, Medtronic representatives notified consignees. Consignees were asked to return a Customer Confirmation Certificate. On 11-Apr-2019, Medtronic initiated the US follow up communications via hand-delivery and UPS 2-day delivery mailings to the March 2019 notification consignees and risk managers identified as part of the April 2019 scope expansion. Consignees are asked to quarantine and return unused affected product. The consignees are asked to return a confirmation form, acknowledging they have received the notification and have taken the requested action. Beginning 10-May-2019, Medtronic initiated additional communications via UPS 2-day delivery to 23 consignees in the US who were mailed the April 2019 notification with inaccurate product inventory reports. This communication included updated customer inventory reports. Communication was also initiated via UPS 2-day delivery to one consignee who did not receive the April 2019 notification, but did receive affected product. The consignees were asked to quarantine and return unused affected product. The consignees are asked to return a confirmation form, acknowledging they have received the notification and have taken the requested action. Beginning 10-Jun-2019, communication and retrieval activities will be initiated with all consignees who have received affected product (original and expanded scope) according to Medtronic records. Consignees will be asked to quarantine and return all unused affected product within their possession. Consignees will be asked to confirm receipt of this June 2019 FCA notification even if they have already confirmed notification of previous communications.
Quantity in commerce: 55 units
Distribution: Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom
Product codes and lots: GTIN: 00613994822970 All Lot/Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2603-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2562-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2563-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2564-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2565-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2566-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2567-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2568-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2569-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2570-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2571-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2572-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2573-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2574-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2575-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2576-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2577-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2578-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2579-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2580-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2581-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2582-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2583-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2584-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2585-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2586-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2587-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2588-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2589-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2590-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2591-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2592-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2593-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2594-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2595-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2596-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2597-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2598-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2599-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2600-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2601-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2602-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2603-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2604-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2605-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2606-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2607-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2608-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2609-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2610-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2611-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2612-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2613-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2614-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2615-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2616-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2617-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2618-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2619-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2620-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2621-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2622-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2623-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2624-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2625-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2626-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2627-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2628-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2629-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2630-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2631-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2632-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2633-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2634-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2635-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2636-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2637-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2638-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2639-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2640-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2641-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2642-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2643-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2644-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2645-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2646-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2647-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2648-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2649-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2650-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2651-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2652-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2653-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2654-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2655-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2656-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2657-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2658-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2659-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2660-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2661-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2662-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2663-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2664-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2665-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2666-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2667-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2668-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2669-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2670-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2671-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2672-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2673-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2674-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2675-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2676-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2677-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2678-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2679-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2680-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2681-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2682-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2683-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2684-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2685-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2686-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2687-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2688-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2689-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2690-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2691-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2692-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2693-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2694-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2695-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2696-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2697-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2698-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2699-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2700-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2701-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2702-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2703-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2704-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2705-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2706-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2707-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2708-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2709-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2710-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2711-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2712-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2713-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2714-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2715-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2716-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2717-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2718-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2719-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2720-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2721-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2722-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2723-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2724-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2725-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2726-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2727-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2728-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2729-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2730-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2731-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2732-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2733-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2734-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2735-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2736-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2737-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2738-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2739-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2740-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2741-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2742-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2743-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2744-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2745-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2746-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2747-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2748-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2749-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2750-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2751-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30
Z-2752-2019	Class I	Completed	Voluntary: Firm initiated	2019-10-09	2019-09-30

Product code DQY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)