Severity
Critical
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 wit
Reported: February 14, 2024 Initiated: January 3, 2024 #Z-0842-2024 1,560 systems as of 12/8/2023 units
Thoratec Corp. issued this FDA Devices recall on February 14, 2024. Classified as Critical severity (Class I). Approximately 1,560 systems as of 12/8/2023 units are affected. The recall was issued because: Due to software and controller systems that results in unexpected pump start or pump stop.. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0842-2024) was formally reported on February 14, 2024, with the manufacturer initiating the action on January 3, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Thoratec Corp. is listed as the recalling firm, operating out of Pleasanton, CA. Federal records indicate 1,560 systems as of 12/8/2023 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Due to software and controller systems that results in unexpected pump start or pump stop. Distribution data in the federal record shows the product reached: 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, Si…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
1,560 systems as of 12/8/2023
Related Recalls
6
6 from same agency
Product Description
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.
Reason for Recall
Due to software and controller systems that results in unexpected pump start or pump stop.
Details
- Recalling Firm
- Thoratec Corp.
- Units Affected
- 1,560 systems as of 12/8/2023
- 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.
- Location
- Pleasanton, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0842-2024 |
| Date reported | February 14, 2024 |
| Date initiated | January 3, 2024 |
| Recalling firm | Thoratec Corp. |
| Units affected | 1,560 systems as of 12/8/2023 |
| 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, Swit… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was 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.. Recalled by Thoratec Corp.. Units affected: 1,560 systems as of 12/8/2023.
Why was this product recalled? ▼
Due to software and controller systems that results in unexpected pump start or pump stop.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Critical. Recall number: Z-0842-2024.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0842-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).