Recall Z-1941-2015 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
| Date | Jul 1, 2015 (initiated Apr 27, 2015) |
| Status | Terminated |
| Reason | One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label. |
| Root cause | Employee error |
| Action | Boston Scientific sent an Urgent Medical Device Recall Removal letter dated April 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected product in their inventory, quarantine the affected product immediately and return to Boston Scientific in accordance with the enclosed recall instructions. Customers will receive replacements for all recalled product that is returned to Boston Scientific. Customers were instructed to forward the recall notification to their custom |
| Quantity | 39 units |
| Distribution | Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. . |
| 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 |