Cervical/endometrial Applicator

Recall Summary Nucletron BV is recalling a cervical/endometrial applicator used in hospitals and pharmacies in New Zealand due to a need to issue updated guidance on its use. This is classified as a Class I recall, which is the most serious type. The manufacturer will be providing advice to healthcare facilities about how to properly use this medical device.

Recalling firm

Elekta Pty Limited - New Zealand Branch

Product

cervical/endometrial Applicator. [Device]. Model: Brachytherapy applicator, remote afterloading, Cervical/Endometrial

Reason

The manufacturer are informing customers of a safety concern regarding the detachment of the tip of the Intrauterine tube (IU tube) with a 4mm diameter. Inadequate application of the epoxy adhesive between the tip and the inner and end surfaces of the fibre tube may contribute to tip detachment., If the tip detaches during a procedure and is retained in the body there is risk of reduced fertility, inflammation and pain.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-04-01

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/451639bf-79cb-4a53-a53b-f61d339b0a98