Z-1740-2024Class II

The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque...

Name: Z-1740-2024 The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque...
Creator: Stryker Neurovascular
Published: 2024-04-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-04-03 / Open, Classified / root cause: sterility

FDA source

Stryker Neurovascular began a recall of The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the... on 2024-04-03. FDA classified it as Class II and gives the reason as "Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1740-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-03
Posted: 2024-05-01
Recalling firm: Stryker Corp.
Product: The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.
Product code: DQY Catheter, Percutaneous
Reason for recall: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: On 4/3/24, recall notices were mailed to Supply Chain Management/ Recall Coordinator/ Inventory Managers informing them: 1) Segregate the affected units in a secure location for return to the firm. Circulate this Recall-Removal notice internally to all interested/affected parties. 2) Maintain awareness of this communication internally until all required actions have been completed within your facility. 3) Inform the firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so the firm can inform the recipients appropriately. 4) Inform the firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: [email protected]) 5) Complete and return the customer response form to [email protected]
Quantity in commerce: 43
Distribution: US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.
Product codes and lots: UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1740-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-01

Product code DQY

K133177Class IIModified Hd Guide CatheterConcentric Medical, Inc. / cleared 2014-02-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)