Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37442 |
| Brand Name: | HM3 LVAS Implant Kit (ABT, MDR) |
| Model: | Apical Coring Knife (1050) part of the HeartMate 3™ LVAS |
| Affected: | Kit Model Numbers: 106524INT |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | Abbott Medical (USA) |
| Brand Name: | HeartMate 3 LVAS Implant Kit, 106524INT |
| Model: | Apical Coring Knife (1050) part of the HeartMate 3™ LVAS |
| Affected: | Kit (Model Numbers: 106524INT) |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | Thoratec Corporation |
| Issue: | 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 inconvenience or extended procedure time. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/9/2026 |
