Reported Dec 8, 2021 · Ongoing

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

Thoratec Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Thoratec Corp. · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270

Is this the product you have?

  • Abbott HeartMate Touch Communication System
  • REF
    • HMT1100 (US)
    • HMT1100-R (Rental US)
    • HMT1150 (EU)
Lot codes and dates
  • All serial numbers.
Amount recalled
988

Where it was sold

Why it was recalled

If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.