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U.S. Department of Health and Human Services

Class 2 Device Recall TRUE Dilatation Balloon Valvuloplasty Catheter

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 Class 2 Recall
TRUE Dilatation Balloon Valvuloplasty Catheter
see related information
Date Posted June 21, 2013
Recall Status1 Terminated on July 17, 2013
Recall Number Z-1566-2013
Recall Event ID 65343
Premarket Notification
510(K) Number
K121083 
Product Classification Balloon Aortic Valvuloplasty - Product Code OZT
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.
Code Information All lot numbers lower than PLN00749 are subject to this recall.
Recalling Firm/
Manufacturer
Loma Vista Medical
863 Mitten Rd Ste 100A
Burlingame, California 94010-1307
For Additional Information Contact Alexander Q. Tilson
650-490-4747 Ext. 115
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Process Design
Action The firm sent an "URGENT VOLUNTARY DEVICE REMOVAL" letter dated March 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 2379 units
Distribution Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OZT and Original Applicant = LOMA VISTA MEDICAL
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