Date Initiated by Firm |
March 18, 2013 |
Date Posted |
June 21, 2013 |
Recall Status1 |
Terminated 3 on July 17, 2013 |
Recall Number |
Z-1566-2013 |
Recall Event ID |
65343 |
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 CA 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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = OZT and Original Applicant = LOMA VISTA MEDICAL
|