Recall Z-1566-2013 ยท OZT Balloon Aortic Valvuloplasty
Loma Vista Medical
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.
| Date | Jun 21, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA Loma Vista Medical, Oct 11, 2012 |