Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective c
FDA device recall Z-2350-2024 · posted 2024-07-12 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KNS
- Quantity affected
- 256 US, 39 OUS
- Distribution
- Domestic distribution nationwide.
- Date initiated
- 2024-06-12
- Date posted
- 2024-07-12
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOTOME RX MODEL # 4515, 4516 (K013153) | Boston Scientific Corp | 2001-10-19 |