Key facts
| Recalling firm | Thoratec LLC |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits |
| Classification | Class II |
| Recall number | Z-2519-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Due to 11 volt Backup Battery failures. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the (additional items listed in FDA's full record) -- and the recall number Z-2519-2026. If it matches, stop using or distributing it and contact Thoratec LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Thoratec LLC and the affected product is described in FDA's record as: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to 11 volt Backup Battery failures.. The recall is tracked under FDA recall number Z-2519-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
Thoratec LLC’s FDA history
Argus HQ has recorded 3 total FDA actions tied to Thoratec LLC: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the (additional items listed in FDA's.
- Has Thoratec LLC had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 3 total FDA actions tied to Thoratec LLC, including 3 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2519-2026.
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Related enforcement actions
Full FDA history for Thoratec LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Brand Name: HeartMate Product Name: HeartMate 3" System… by Thoratec LLC — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-thoratec-llc-z-2519-2026
"FDA Class II Recall: Brand Name: HeartMate Product Name: HeartMate 3" System… by Thoratec LLC — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-thoratec-llc-z-2519-2026.
Argus HQ Research. "FDA Class II Recall: Brand Name: HeartMate Product Name: HeartMate 3" System… by Thoratec LLC — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-thoratec-llc-z-2519-2026.
@misc{argushq_argushq_ai_recall_fda_recall_thoratec_llc_z_2519_2026_2026,
title = {FDA Class II Recall: Brand Name: HeartMate Product Name: HeartMate 3" System… by Thoratec LLC — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-thoratec-llc-z-2519-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗