Food, drugs, devices › Thoratec LLC
Device recall: HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant K
FDA enforcement event 94973 is a device recall by Thoratec LLC of Pleasanton, CA, initiated 25 Jun 2024 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Thoratec LLC has 6 enforcement events on this register, with a median of 2 product records 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 LLC, Pleasanton, CA.
Reason for recall
"Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop"
Distribution
"US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2583-2024 | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3… | 694 | Class II | Ongoing | 21 Aug 2024 |
Context
Other enforcement events for Thoratec LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 May 2026 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Softw | Device | Class II | 3 |
| 10 Oct 2025 | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-c | Device | Class II | 1 |
| 9 Oct 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, Hear | Device | Class II | 4 |
| 23 Jun 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A | Device | Class I | 2 |
| 13 Mar 2025 | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with Hear | Device | Class I | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia,…"
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.