CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
HeartMate 3 LVAS Implant Kit, Sterile recalled by Thoratec
Thoratec is recalling HeartMate 3 LVAS Implant Kit, Sterile, distributed nationwide in the US. The recall was initiated on 30 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2348-2019
- FDA event ID
- 83357
- Recalling firm
- Thoratec, Pleasanton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2019
- FDA classified
- 22 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2019 | Recall initiated by company | |
| 22 Aug 2019 | Classified by FDA | +145 days |
| 28 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Where it was distributed
Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or higher. UDI/GMDN 00813024013297 / 47533
Where was it sold?
Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83357This product is part of a recall event; the main page for the event is Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile recalled | Thoratec | Sterility | Nationwide |
More recalls from Thoratec
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| Device | CLASS II | HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| Device | CLASS II | HeartMate 3" System Controller recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| Device | CLASS II | CentriMag Blood Pump recalled by Thoratec | Thoratec | Particulate Matter | Nationwide |
| Device | CLASS II | HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |