Recall Z-2350-2024— Boston Scientific Corporation

Name: FDA recall Z-2350-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-12

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-06-12. It names one FDA 510(k) clearance: K013153. Product: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.. 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-06-12
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K013153 — AUTOTOME RX MODEL # 4515, 4516Boston Scientific Corp·cleared 2001-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.