Recall Z-2350-2024 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Boston Scientific Corporation
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
| Date | Jul 12, 2024 (initiated Jun 12, 2024) |
| Status | Open, Classified |
| Reason | Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure. |
| Root cause | Process control |
| Action | All customers notified via courier on June 12, 2024 - notice was titled "Urgent Medical Device Removal." Customers were informed to cease further use or distribution of any remaining affected product. Product should be segregated and returned to the firm. For more information, please reach out to your local Boston Scientific representative. |
| Quantity | 256 US, 39 OUS |
| Distribution | Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013153 | AUTOTOME RX MODEL # 4515, 4516 Boston Scientific Corp, Oct 19, 2001 |