Food, drugs, devices › Thoratec Corp.
Device recall: Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
FDA enforcement event 83357 is a device recall by Thoratec Corp. of Pleasanton, CA, initiated 30 Mar 2019 and classified Class II, with 2 product records.
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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 24 Aug 2020. 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
"Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure."
Distribution
"Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2348-2019 | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System | 7200 left ventricular assist systems | Class II | Terminated | 28 Aug 2019 |
| Z-2349-2019 | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266 | 149 outflow graft units | Class II | Terminated | 28 Aug 2019 |
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: "Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure."
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: "Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Aug 2020. "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.