The Recall Desk
HighFDA (Devices)·Z-0308-2022·Announced 2021-12-08

Abbott HeartMate Touch System App may fail due to Bluetooth interference issue

The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall affecting a critical left ventricular assist system communication interface. Although no illnesses or injuries have been reported, the app malfunction poses a potential risk to patient safety by temporarily preventing communication with an implanted cardiac support device, fitting the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration is recalling the Abbott HeartMate Touch Communication System (Models HMT1100 for U.S. use, HMT1100-R for U.S. rental, and HMT1150 for European use). This recall affects 988 devices distributed worldwide, including all U.S. states and 21 countries, with all serial numbers included.

The HeartMate Touch system is a mobile application that allows patients to communicate with their implanted left ventricular assist system. A Bluetooth connectivity issue occurs when the system attempts to establish a connection while nearby Bluetooth-enabled devices are also advertising for connection—the resulting interference may cause the Touch System app to close or fail to open.

When Bluetooth interference occurs, patients may experience temporary app unavailability and loss of communication access. However, once the Bluetooth adapter successfully connects and the connection is maintained, all system functionality is unaffected and the device operates as designed.

Patients and healthcare providers should contact Thoratec Corp. or Abbott for guidance on managing this issue and to inquire about any available updates or mitigation strategies.

The recalled product

Product
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Manufacturer
Thoratec Corp.
Category
Medical Device — Cardiac Assist Communication System
Hazard
  • bluetooth-interference
  • app-malfunction
  • communication-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category