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InterValve Inc recalls InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Car
Recalled May 21, 2014 · FDA recall Z-1621-2014 · InterValve
Hazard
Leak issues were discovered through accelerated age testing. · FDA Class II
Units
2
Sold at
Distribution to TN only
Description
Leak issues were discovered through accelerated age testing.
Product
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Manufacturer(s)
InterValve Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →