Autotome RX Cannulating Sphincterotome Recalled for Potential Device Malfunction
Boston Scientific recalls the Autotome RX Cannulating Sphincterotome due to foreign material on the cutting wire that may prevent proper device function and extend procedure time. No injuries reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a manufacturing defect that may impair device function during a critical medical procedure. Although no injuries or illnesses have been reported, the defect presents a risk of harm through procedure prolongation.
Plain-English summary
Boston Scientific Corporation is recalling the Autotome RX 20mm CUT WIRE Cannulating Sphincterotome (Material Number M00545170). This medical device is used to help physicians selectively cannulate the bile duct during endoscopic procedures. The company initiated the recall because foreign material may be present on the enclosed section of the cutting wire.
The foreign material may prevent the sphincterotome from bowing optimally, which could extend the duration of the endoscopic procedure. No illnesses or injuries have been reported to date. The recall affects 256 units distributed in the United States and 39 units distributed internationally.
Affected devices are identified by UDI-DI (GTIN) 08714729444749, Lot 33280747, with an expiration date of January 23, 2027. Healthcare providers in possession of recalled units should stop using them and contact Boston Scientific for replacement or return instructions.
The recalled product
- Product
- Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
- Manufacturer
- Boston Scientific Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23
- 2027
Distribution
Distributed nationwide across the United States.
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