Z-1729-2020Class II

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050...

Name: Z-1729-2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050...
Creator: Boston Scientific
Published: 2020-03-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-03-09 / Open, Classified

FDA source

Boston Scientific began a recall of Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit on 2020-03-09. FDA classified it as Class II and gives the reason as "An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1729-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-09
Posted: 2020-04-01
Recalling firm: Boston Scientific Corporation
Product: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
Product code: EZB Stylet For Catheter, Gastro-Urology
Reason for recall: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
FDA root cause: Component change control
Action: Boston Scientific issued Customer Notification on March 9, 2020 stating reason for recall, health risk and action to take: cease distribution or use of any remaining product affected by this removal should cease immediately; Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Verification Form the quantity of units from each lot/batch that you will bereturning. As some of these products within these lots/batches are sold as 5-packs, it is important that all reported quantities represent the actual number of single units being returned and not the number of cartons/boxes or multi-packs; If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth is to the hospital level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital within your network, please ensure that this notification is forwarded to them.
Quantity in commerce: 25,956
Distribution: Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Product codes and lots: Lot Numbers: 24423656, 24423820, 24424087, 24427952, 24427959, 24428330, 24430010, 24437882, 24440182, 24440998, 24444952, 24446611, 24447516, 24447658, 24447722, 24447735, 24451828, 24452126, 24452132, 24452266, 24454238, 24455297, 24455381, 24455732, 24460452, 24460458, 24466032, 24487805, 24493956, 24494611, 24498583, 24498730, 24498732, 24499924, 24501439, 24506583, 24563429, 24563891, 24564727, 24564729, 24569684, 24570465, 24571203, 24579763, 24599358, 24609013, 24609991, 24614307, 24615296, 24620493, 24621357, 24621789, 24622541, 24623111, 24623117, 24623321, 24623461, 24623472, 24640257, 24661651, 24662199, 24663152, 24663562, 24663570, 24665001, 24665005, 24665100, 24665108, 24665990, 24666401, 24670677, 24672232, 24672553, 24678045, 24678047, 24681044, 24699798, 24700605, 24702016, 24708365, 24708371, 24709540, 24709550, 24710261, 24716280, 24716623, 24719303, 24723783, 24724284, 24732445, 24732731, 24738283, 24751717, 24756104, 24758578, 24763250, 24765356, 24766287, 24766401, 24772737, 24773528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1729-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1729-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1730-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1731-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1732-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1733-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1734-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1735-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1736-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1737-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1738-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1739-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17
Z-1740-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code EZB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)