InterValve V8 Balloon Aortic Valvuloplasty Catheter recall
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for…
Why was InterValve V8 Balloon Aortic Valvuloplasty Catheter recalled?
Leak issues were discovered through accelerated age testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 101637, 101640
- Product
- InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for…
- Recalling firm
- InterValve Inc
- Quantity
- 2
- Distribution
- Distribution to TN only
- Recall date
- May 21, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)