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U.S. Department of Health and Human Services

Class 2 Device Recall Stretch VL Ureteral Stent Set

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  Class 2 Device Recall Stretch VL Ureteral Stent Set see related information
Date Initiated by Firm March 09, 2020
Date Posted April 01, 2020
Recall Status1 Open3, Classified
Recall Number Z-1737-2020
Recall Event ID 85227
Product Classification Stylet for catheter, gastro-urology - Product Code EZB
Product Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035
Sensor
UPN: M006185155080
Code Information Lot Numbers: 24755840 
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 2		 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 57 units
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.
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