Recall Z-1740-2020 ยท EZB Stylet For Catheter, Gastro-Urology
Boston Scientific
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
| Date | Apr 1, 2020 (initiated Mar 9, 2020) |
| Status | Open, Classified |
| 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 sin |
| Quantity | 19 units |
| Distribution | Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.