Affera Hexagen Rf Generators And Hexapulse Pf Generators
- Recalling firm
- Medtronic New Zealand Limited
- Product
- Affera HexaGEN RF Generators and HexaPulse PF Generators. [Device]. Model: Model - AFR-00004. Affected: Affected Software - 1.1.5 and 1.3.1
- Reason
- As of March 2026, Medtronic has received complaints related to software anomalies. Potential impacts associated with these anomalies include minor procedure delay, and improbable, theoretical risks of collateral tissue injury, transient heart block, or cancelled procedure.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-07-02
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a3f703a9-1fe1-4fdd-936a-9ba2e9a6eadd