Recall Z-2328-2021— Boston Scientific Corporation

Name: FDA recall Z-2328-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-23

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-07-23. FDA's recall record names no specific 510(k) clearance for this event. Product: TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE). Reason: Potential for leaks and loosening at the patient catheter connection.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-07-23
Firm location: Maple Grove, MN, United States

Product description

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Reason for recall

Potential for leaks and loosening at the patient catheter connection

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