Z-2350-2024 Class II Ongoing
FDA device recall Z-2350-2024 was initiated by Boston Scientific Corporation on Jun 12, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 256 US, 39 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2024
- Initiation Date
- Jun 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256 US, 39 OUS
Product Description
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
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.
Distribution Pattern
Domestic distribution nationwide.
Code Information
UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2350-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026