Recall Z-1851-2012 ยท FDI Snare, Flexible
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and c
| Date | Jun 21, 2012 (initiated May 16, 2012) |
| Status | Terminated |
| Reason | Difficulty in extending snare loop from the catheter |
| Root cause | Process control |
| Action | Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. 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. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000. |
| Quantity | 1970 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941750 | PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES Boston Scientific Corp, Nov 1, 1994 |