FDA Medical Device Recalls (openFDA)
Boston Scientific: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
- Recall number
- Z-1729-2020
- Recalling firm
- Boston Scientific
- Product
- Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
- Status
- Open, Classified
- Initiated
- 2020-03-09
- Posted
- 2020-04-01
- Terminated
- not on file
- Reason
- 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
- 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
- 25,956
- Distribution
- Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EZB
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28