Recall Z-1621-2014— InterValve Inc

Name: FDA recall Z-1621-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-14

Class II · Terminated

Class II FDA medical device recall by InterValve Inc, initiated 2014-03-14, terminated 2014-06-16. It names one FDA 510(k) clearance: K133607. Product: InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.. Reason: Leak issues were discovered through accelerated age testing..

Recalling firm: InterValve Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-14
Terminated: 2014-06-16
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K133607 — V8 TRANSLUMINAL BAV CATHETERIntervalve, Inc.·cleared 2014-02-11

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

InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.

Reason for recall

Leak issues were discovered through accelerated age testing.

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