Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Reported: July 24, 2024 Initiated: June 12, 2024 #Z-2350-2024
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 256 US, 39 OUS
- Distribution
- Domestic distribution nationwide.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.. Recalled by Boston Scientific Corporation. Units affected: 256 US, 39 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2350-2024.
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