FDAFDA · Food and drugs·Recall number Z-1621-2014
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Published May 21, 2014 · Recall initiated: March 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Leak issues were discovered through accelerated age testing.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- InterValve Inc
- Distributor
- Distribution to TN only
- Lot
- Lot numbers: 101637, 101640
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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