Recall Z-0710-2014 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
| Date | Jan 10, 2014 (initiated Dec 18, 2013) |
| Status | Terminated |
| Reason | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size |
| Root cause | Process control |
| Action | Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. For questions regarding this recall call 508-382-9555. |
| Quantity | 39 units |
| Distribution | Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102082 | EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 Boston Scientific Corp, Aug 23, 2010 |