FDA Device recall Z-2350-2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170 by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2350-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-12 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
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.
Identifiers
| code_info | UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2350-2024%22
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