FDAAugust 12, 2026
Abiomed Impella Optical Controller Recall Over Purge Cassette Recognition Issues (Aug 12, 2026)
FDA published this notice on August 12, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- August 12, 2026
- Recall class
- Class I
- Reason given by the agency
- The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
- Distribution
- Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;
- Official source
- the notice at its source
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Source: FDA.