Reported Jul 3, 2013 · Terminated
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x…
Loma Vista Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Loma Vista Medical · 863 Mitten Rd Ste 100A · Burlingame, CA · 94010-1307
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13 |
| 2 | Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm |
| 3 | Intended to be used for balloon aortic valvuloplasty. |
- Lot codes and dates
- All lot numbers lower than PLN00749 are subject to this recall.
- Amount recalled
- 2379 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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