Recall Z-2378-2015— Boston Scientific Corporation

Name: FDA recall Z-2378-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-31

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2015-07-31, terminated 2016-02-05. It names one FDA 510(k) clearance: K111182. Product: AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.. Reason: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Terminated: 2016-02-05
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SETMedrad, Inc.·cleared 2011-05-24

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

AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

Reason for recall

AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

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