Recall Z-1566-2013— Loma Vista Medical

Name: FDA recall Z-1566-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-18

Class II · Terminated

Class II FDA medical device recall by Loma Vista Medical, initiated 2013-03-18, terminated 2013-07-17. It names one FDA 510(k) clearance: K121083. Product: TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.. Reason: Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum..

Recalling firm: Loma Vista Medical
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Terminated: 2013-07-17
Firm location: Burlingame, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K121083 — TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINALoma Vista Medical·cleared 2012-10-11

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

TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

Reason for recall

Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.

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