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Lower risk Medical device recall · FDA · Published October 22, 2021

Abbott HeartMate Touch: Bluetooth Interference May Cause App Failure

Abbott HeartMate Touch Communication System (HMT1100, HMT1100-R, HMT1150) may experience app crashes due to Bluetooth interference with nearby devices. No action needed as the device continues to function normally.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0308-2022Medical deviceThoratec ›
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Contact the company

Recalling firmThoratec Corp.6035 Stoneridge Dr · Pleasanton, CA 94588-3270
✎ GovInfoNow plain-language explainer

Abbott's HeartMate Touch Communication System (HMT1100, HMT1100-R, HMT1150) may close or fail to open its app if Bluetooth interference occurs with nearby devices. This does not affect the device's normal operation once connected. Read more at govinfonow.com/recall/61634-abbott-heartmate-touch-bluetooth-interference-may-cause-app-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/61634-abbott-heartmate-touch-bluetooth-interference-may-cause-app-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0308-2022

Cite this page

“Abbott HeartMate Touch: Bluetooth Interference May Cause App Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61634-abbott-heartmate-touch-bluetooth-interference-may-cause-app-failure. Based on FDA recall #Z-0308-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0308-2022%22&limit=1).

Thoratec Corp. recalled the Abbott HeartMate Touch Communication System on Oct. 22, 2021, after the FDA announced that Bluetooth interference could cause the system app to close or fail to open. The Food and Drug Administration issued the voluntary Class II recall affecting 988 units distributed worldwide.

How to tell if you have it

  • Brand: Thoratec
  • Product: Abbott HeartMate Touch Communication System
  • REF: HMT1100 (US)
  • REF: HMT1100-R (Rental US)
  • REF: HMT1150 (EU)
  • Serial numbers: All

The hazard

The hazard involves Bluetooth connectivity interference if the LVAS communication system attempts to establish a connection while another Bluetooth-enabled device is nearby and advertising for a connection. This may cause the system App to close or fail to open, though all functionality remains unaffected once the Bluetooth adaptor is connected.

Context

GovInfoNow's records show Thoratec Corp. has 8 other recalls on record since March 1, 2019. Recent Thoratec recalls include a May 8, 2024 recall for HeartMate Monitor screen errors and a March 1, 2024 recall for the HeartMate 3 LVAS Implant Kit potential leak path. Other recent recalls of similar products include a Feb. 19, 2024 Thoratec HeartMate 3 LVAS extrinsic outflow graft obstruction risk.

How to tell if you have this one

Check for the model numbers HMT1100 (US), HMT1100-R (Rental US), or HMT1150 (EU) on your device. All units have unique serial numbers.

  • Brand
    Thoratec
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Ensure the app opens normally after Bluetooth connection to confirm no interference issues.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 38 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, IL, PA, AR, GA, WI, AZ, TN, TX, MA, NE, CA, VA, NC, OH, MI, DC, IN, NJ, CT, OK, MD, NY, ME, IA, SC, KY, LA, OR, NM, WA, SD, MO, NV, HI, AL, MS, UT, KS and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Oct 22, 202112. FDA classified it Class II: Nov 26, 202123. Published in FDA’s Enforcement Report: Dec 8, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0308-2022 (October 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0308-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA