Hm3 Lvas Implant Kit (abt, Mdr)

Recall Summary The HeartMate 3 LVAS Implant Kit (Model 106524INT), specifically the Apical Coring Knife Handle, is being recalled because some handles have dimensional variations that may not form the intended shape evenly. Although the knife still functions properly for cutting heart tissue and all previous uses were completed successfully, the variation could potentially cause inconvenience or extend procedure time during implant surgery. This recall affects medical facilities in New Zealand.

Recalling firm

Abbott Medical New Zealand Limited

Product

HM3 LVAS Implant Kit (ABT, MDR). [Device]. Model: Apical Coring Knife (1050) part of the HeartMate 3™ LVAS; Apical Coring Knife (1050) part of the HeartMate 3™ LVAS. Affected: Kit Model Numbers: 106524INT; Kit (Model Numbers: 106524INT). Also covers: HeartMate 3 LVAS Implant Kit, 106524INT

Reason

The manufacturer identified dimensional variation in certain Apical Coring Knife Handles that are uneven when forming the intended �T� configuration. Technical evaluation confirmed that, despite this variation, the handle consistently forms a functional interface, maintains structural engagement, and the coring knife is able to cut cardiac tissue effectively. Medical assessment determined that this condition is not associated with serious adverse health consequences, as all reported uses of the coring knife were successfully completed. There is potential for this problem to cause...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-01

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/2d148eb2-1e70-402a-9498-39f4ca9aa488