Thoratec Corp.: 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

Hazard

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

Details from the source

Reason for recall: Due to software and controller systems that results in unexpected pump start or pump stop. Distribution: 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. Quantity: 1,560 systems as of 12/8/2023 Lot/code info: 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 DMPWW0

UPC codes

05415067032058, 05415067033758, 05415067032041

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.