Balloon Aortic Valvuloplasty
FDA adverse event reports and recall history for balloon aortic valvuloplasty (product code OZT), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 395
- Deaths
- 35
- Injuries
- 106
- Malfunctions
- 249
Reports per year
Source: FDA adverse event reports by year received, 2013–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2014-05-15TerminatedNonconforming Material/Component
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Leak issues were discovered through accelerated age testing.
- 2013-06-21TerminatedProcess design
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
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