TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4
FDA device recall Z-1566-2013 · posted 2013-06-21 · Terminated
Recall details
- Recalling firm
- Loma Vista Medical
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- OZT
- Quantity affected
- 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.
- Date initiated
- 2013-03-18
- Date posted
- 2013-06-21
- Date terminated
- 2013-07-17
- Location
- Burlingame, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA (K121083) | Loma Vista Medical | 2012-10-11 |