1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF…
Medical device recall Z-0842-2024. Published in FDA’s Enforcement Report on Feb 14, 2024.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 14, 2024. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,560 systems as of 12/8/2023 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to software and controller systems that results in unexpected pump start or pump stop.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. 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.
1,560 systems as of 12/8/2023, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
HeartMate Touch Communication System Model Number: HMT1100 UDI-DI Code: 05415067032058 Serial Numbers: DMPV40AAHP83 DMPVN1DFHP83 DMPVQ2JSHP51 DMPVQ374HP51 DMPVR6EXHP51 DMPVW1KDHP51 DMPW90USHP83 DMPWD118HP83 DMPWG096HP83 DMPWH036HP83…
Every code shown here, 1,988 characters
HeartMate Touch Communication System Model Number: HMT1100 UDI-DI Code: 05415067032058 Serial Numbers: 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 DMPWT0PJHP83 DMPWT0URHP83 DMPWT0YHHP83 DMPWT118HP83 DMPWV09DHP83 DMPWV0BHHP51 DMPWV0C5HP83 DMPWV0C6HP83 DMPWV0CCHP83 DMPWV0CRHP83 DMPWV0DRHP83 DMPWV0DVHP83 DMPWV0E8HP83 DMPWV0EDHP83 DMPWV0FFHP83 DMPWV0FJHP83 DMPWV0FTHP83 DMPWV0GJHP83 DMPWV0GXHP83 DMPWV0H4HP83 DMPWV0H9HP83 DMPWV0J6HP83 DMPWV0JEHP83 DMPWV0JNHP83 DMPWV0K2HP83 DMPWV0K9HP83 DMPWV0LDHP83 DMPWW004HP83 DMPWW00KHP83 DMPWW00LHP83 DMPWW012HP83 DMPWW019HP83 DMPWW01BHP83 DMPWW04JHP83 DMPWW06PHP83 DMPWW095HP83 DMPWW0DKHP83 DMPWW0E9HP83 DMPWW0F1HP83 DMPWW0FGHP83 DMPWW0G7HP83 DMPWW0GAHP83 DMPWW0GBHP83 DMPWW0GLHP83 DMPWW0GWHP83 DMPWW0H0HP83 DMPWW0H1HP83 DMPWW0H7HP83 DMPWW0HLHP83 DMPWW0J7HP83 DMPWW0JGHP83 DMPWW0JZHP83 DMPWW0KDHP83 DMPWW0KKHP83 DMPWW0KWHP83 DMPWW0LCHP83 DMPWW0MCHP83 DMPWW0MKHP83 DMPWW0PWHP83 DMPWW0Q9J28L DMPWW0R5HP83 DMPWW0RGHP83 DMPWW0S5HP83 DMPX10UAHP51 DMPX10UDHP51 DMPX10ZMHP51 DMPX11Z2HP51 DMPX127EHP51 DMPX12GXHP51 DMPX12J0HP51 DMPX12JJHP51 DMPX12MKHP51 DMPX12RPHP51 DMPX12RRHP51 DMPX12S2HP51 DMPX12UPHP51 DMPX143YHP51 DMPX1AYLHP50 DMPX20FNHP83 DMPX20FPHP83 DMPX20G0HP83 DMPX20VNHP83 DMPX20VVHP83 DMPX20W2HP50 DMPX20ZRHP51…
FDA’s list runs to 20,598 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 3, 2024.
- FDA classified it on Feb 2, 2024.
- FDA’s Enforcement Report published it on Feb 14, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Thoratec Corp., of Pleasanton, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 20,598 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.