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Recall Observatory FDA recall evidence

Device product

Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

Z-2350-2024

June 12, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 94827
Status
Ongoing
Classification
Class II
Quantity
256 US, 39 OUS
Official record key
device-enforcement:Z-2350-2024

Official wording

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.

Code information: UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign material