Radio-frequency Ablation System Probe Cannula, Reusable

Boston Scientific is recalling reusable probe cannulas used in radio-frequency ablation systems distributed to hospitals, pharmacies, and laboratories in New Zealand. The specific reason for the recall was not detailed in the available information. The company has classified this as a Class I recall, which is the most serious type, and is requesting the product be returned to the supplier.

Recalling firm

Boston Scientific NZ Ltd

Product

Radio-frequency ablation system probe cannula, reusable. [Device]. Model: TCNTM (Thermo Couple Nitinol). Affected: All batches

Reason

The manufacturer has determined that the Thermo Couple Nitinol (TCN) and Cosman Straight Kit (CSK) Reusable RF Electrodes may, not consistently meet the expected performance levels throughout the specified 20 sterilisation cycles for re-use. This determination was based on recent review of internal laboratory testing. Complaint data indicates that the most frequently reported problems relate to electrode not heating, temperature-reading problems and device damage, which have led to prolonged, procedure. A small number of cases (0.15%) reported unintentional burns, allergic reactions,...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-05-06

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/5b7e8066-1122-4440-b8a2-3cd8039a0bcc