Reported May 21, 2014 · Terminated
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in…
InterValve Inc.
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: InterValve Inc · 16200 State Highway 7 · Minnetonka, MN · 55345
Is this the product you have?
- InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
- Lot codes and dates
- Lot numbers
101637101640
- Lot numbers
- Amount recalled
- 2
Where it was sold
Why it was recalled
Leak issues were discovered through accelerated age testing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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