Food, drugs, devices › Thoratec Corp.
Device recall: 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. He
FDA enforcement event 93697 is a device recall by Thoratec Corp. of Pleasanton, CA, initiated 3 Jan 2024 and classified Class I, with 1 product record.
FDA defines Class I as 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. 11% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Thoratec Corp. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Thoratec Corp., Pleasanton, CA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0842-2024 | 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… | 1,560 systems as of 12/8/2023 | Class I | Ongoing | 14 Feb 2024 |
Context
Other enforcement events for Thoratec Corp.
All 9 events for Thoratec Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to software and controller systems that results in unexpected pump start or pump stop."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.