Reported Feb 14, 2024 · Ongoing

1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3.…

Thoratec Corp.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
HMT1100HeartMate Touch Communication System
HMT1100-RHeartMate Touch Communication System, Rental
HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.
Lot codes and dates
  • HeartMate
  • Touch Communication System Model NumberHMT1100
  • UDI-DI Code05415067032058
  • Serial Numbers

    1,468 of 1,468 codes

    • DMPV40AAHP83
    • DMPVN1DFHP83
    • DMPVQ2JSHP51
    • DMPVQ374HP51
    • DMPVR6EXHP51
    • DMPVW1KDHP51
    • DMPW90USHP83
    • DMPWD118HP83
    • DMPWG096HP83
    • DMPWH036HP83
    • DMPWL02KHP83
    • DMPWL04QHP83
    • DMPWL05PHP83
    • DMPWL0AMHP83
    • DMPWL0T1HP83
    • DMPWL0XHHP83
    • DMPWL111HP83
    • DMPWL13CHP83
    • DMPWL14XHP83
    • DMPWL19RHP83
    • DMPWL1B7HP83
    • DMPWL1BPHP83
    • DMPWL1CCHP83
    • DMPWL1DVHP83
    • DMPWL21LHP83
    • DMPWL243HP83
    • DMPWL24PHP83
    • DMPWL29YHP83
    • DMPWL2BAHP83
    • DMPWL2DAHP83
    • DMPWM02VHP83
    • DMPWM0B5HP83
    • DMPWN01MHP83
    • DMPWN041HP83
    • DMPWN0A0HP83
    • DMPWN0AVHP83
    • DMPWN0XRJ28L
    • DMPWR0AKHP83
    • DMPWR0AZHP83
    • DMPWR0BSHP83
    • DMPWR0C5HP83
    • DMPWR0CCHP83
    • DMPWR0DWHP83
    • DMPWR10BHP83
    • DMPWR11AHP83
    • DMPWR124HP83
    • DMPWR160HP83
    • DMPWR16ZHP83
    • DMPWR17CHP83
    • DMPWR17SHP83
    • DMPWR19BHP83
    • DMPWR19JHP83
    • DMPWR1D2HP83
    • DMPWR1DTHP83
    • DMPWR1F6HP83
    • DMPWR1MZHP83
    • DMPWT00PHP83
    • DMPWT02RHP83
    • DMPWT0CBHP83
    • DMPWT0NQHP83
    HeartMate Touch Communication System
  • Rental Model NumberHMT1100-R
  • UDI-DI Code05415067033758
  • Serial NumbersDMPWL0Y3HP83 DMPXQ006HP83 DMPXQ031HP83 DMPXQ0C7HP83 DMPXQ0JMHP83 HeartMate
  • Touch Communication System Model NumberHMT1150
  • UDI-DI Code05415067032041
  • Serial Numbers

    87 of 87 codes

    • DMPVJAYAHP51
    • DMPWL1A2HP83
    • DMPWR6PNHP50
    • DMPWV0DGHP51
    • DMPX12NSHP51
    • DMPX13DAHP51
    • DMPX22F4HP50
    • DMPX31NWHP51
    • DMPX50PBHP50
    • DMPX54VFHP50
    • DMPX55LLHP50
    • DMPX55MVHP50
    • DMPX7148HP51
    • DMPX71E7HP51
    • DMPX71RNHP51
    • DMPX75RFHP50
    • DMPX76JYHP50
    • DMPX77NMHP50
    • DMPX77RSHP50
    • DMPX77V5HP50
    • DMPX781ZHP50
    • DMPX789JHP50
    • DMPX78N2HP50
    • DMPX78Q5HP50
    • DMPX78W2HP50
    • DMPXC02HHP50
    • DMPXC04MHP50
    • DMPXC05PHP84
    • DMPXC0E1HP50
    • DMPXC0NKHP51
    • DMPXD1GAHP51
    • DMPXD1PRHP51
    • DMPXG1M1HP51
    • DMPXJ0L8HP83
    • DMPXK01LHP83
    • DMPXK05RHP83
    • DMPXK0BMHP83
    • DMPXK0NSHP83
    • DMPXK1QAHP83
    • DMPXK27PHP83
    • DMPXL0EKHP83
    • DMPXN01WHP51
    • DMPXN03PHP51
    • DMPXN06KHP51
    • DMPXN08NHP51
    • DMPXN0J7HP51
    • DMPXN1AJHP50
    • DMPXN1C3HP50
    • DMPXN1SJHP50
    • DMPXN2A7HP50
    • DMPXN2DUHP50
    • DMPXN2XFHP50
    • DMPXN3B3HP50
    • DMPXN3HWHP50
    • DMPXN3LGHP50
    • DMPXP0E2HP83
    • DMPXP0F4HP83
    • DMPXP0FZHP83
    • DMPXP0PBHP51
    • DMPXP0QAHP51
Amount recalled
1,560 systems as of 12/8/2023

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Due to software and controller systems that results in unexpected pump start or pump stop.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 7:44 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.