| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02055-1 |
| Product Name/Description |
The HeartMate Touch App
Catalogue number: HMT1150
ARTG 353258
(Abbott Medical Australia Pty Ltd - HeartMate Touch Communication System HMT1150 - Multi-purpose electrical stimulation system programmer) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/10/2021 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has received some reports of the HeartMate Touch (HMT) App closing when the user opens the App or prior to connecting to the Bluetooth Adaptor.
This scenario is limited to the HeartMate Touch App only and does not impact any other Bluetooth-enabled devices. Once the HeartMate Touch is connected to the Bluetooth adaptor, barring disconnection, all functionality is unaffected, and the device will continue to operate as expected. This scenario has no impact on preset operations of the blood pump once the blood pump has started running but could delay the initiation of pump support during the implantation procedure, potentially causing harm to a patient including death. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abbott will be communicating with customers to advise of patient management recommendations. |
| Contact Information |
1800 839 259 - Abbott Medical Australia |