Recall Z-1133-2018— Boston Scientific Corporation

Name: FDA recall Z-1133-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-20

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-12-20, terminated 2019-12-13. It names one FDA 510(k) clearance: K142922. Product: SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600. Reason: Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Terminated: 2019-12-13
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K142922 — SpyGlass DS Direct Visualization SystemBoston Scientific Corporation·cleared 2015-01-16

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

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

Reason for recall

Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

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