Class 2 Device Recall Sensor Nitinol Wire with Hydrophilic Tip .035

• Date Initiated by Firm: March 09, 2020
• Date Posted: April 01, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1729-2020
• Recall Event ID: 85227
• Product Classification: Stylet for catheter, gastro-urology - Product Code EZB
• Product: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM; UPN: M0066703051 box 5 ; UPN: M0066703050 single unit
• Code Information: 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
• Recalling Firm/ Manufacturer: Boston Scientific; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Nicole Pshon; 763-494-1133
• Manufacturer 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 Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.