Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InterValve V8 Balloon Aortic Valvuloplasty Catheter Recalled by InterValve Inc Due to Leak issues were discovered through accelerated age testing.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact InterValve Inc directly.
Affected Products
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Quantity: 2
Why Was This Recalled?
Leak issues were discovered through accelerated age testing.
Where Was This Sold?
This product was distributed to 1 state: TN
About InterValve Inc
InterValve Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report