—#208444

Product

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

FDA product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K013153
Affected lot / code info: UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

All customers notified via courier on June 12, 2024 - notice was titled "Urgent Medical Device Removal." Customers were informed to cease further use or distribution of any remaining affected product. Product should be segregated and returned to the firm. For more information, please reach out to your local Boston Scientific representative.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Domestic distribution nationwide.

Timeline

Recall initiated: 2024-06-12
Posted by FDA: 2024-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.