Impella Purge Cassette
Recall Summary Impella Purge Cassettes (Generation 1) are being recalled because they have an increased risk of leaking the rinsing fluid that is supposed to flow through the catheter to prevent blood from entering the blood pump. The affected products include model codes 0043-0003 and 0048-0014, as well as all unexpired Generation 1 Purge Cassettes. The manufacturer has developed an updated Generation 2 version with a lower risk of leaks, and this recall affects hospitals, pharmacies, and laboratories in New Zealand.
- Recalling firm
- Bio-Excel (NZ) Limited trading as Bio-Excel (Australia) Pty Ltd
- Product
- Impella Purge Cassette. [Device]. Model: Purge Cassette, 5 Pack, Impella CP Smart Assist Set. Affected: Product code - 0043-0003, 0048-0014. All Unexpired Generation 1 Purge Cassette(s)
- Reason
- The manufacturer has issued a device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. The purge cassette delivers rinsing fluid to the Impella catheter. The purge fluid flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-11
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/71db3658-caf9-43d6-9c81-11d2948b7508