Automated Impella Controller With Impella Connect
- Recalling firm
- Bio-Excel (NZ) Limited trading as Bio-Excel (Australia) Pty Ltd
- Product
- Automated Impella controller with Impella Connect. [Device]. Model: Product code: 0042-0040-AU - Optical, AIC, Impella Connect, Pkgd, AU. Affected: All lots and serial numbers
- Reason
- The manufacturer has identified an increase in complaints due to purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognize that the purge disc is inserted properly. The manufacturer is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-21
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/30c05f28-4467-4b36-96ab-809be3a20c76