Z-1621-2014 Class II Terminated
FDA device recall Z-1621-2014 was initiated by InterValve Inc on March 14, 2014 and is designated Class II. Reason for recall: Leak issues were discovered through accelerated age testing. The recall status is terminated (terminated June 16, 2014). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- March 14, 2014
- Termination Date
- June 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Reason for Recall
Leak issues were discovered through accelerated age testing.
Distribution Pattern
Distribution to TN only
Code Information
Lot numbers: 101637, 101640