CLASS I Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
HeartMate II LVAD Pump and Pock Controller Kit recalled by Thoratec
Thoratec is recalling HeartMate II LVAD Pump and Pock Controller Kit, distributed nationwide in the US. The recall was initiated on 4 Mar 2014 and the FDA has classified it as Class I.
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-229-2014
- FDA event ID
- 67639
- Recalling firm
- Thoratec, Pleasanton, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Mar 2014
- FDA classified
- 21 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Mar 2014 | Recall initiated by company | |
| 21 Mar 2014 | Classified by FDA | +17 days |
| 2 Apr 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Product as listed by the FDA
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Where it was distributed
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Which lots are affected?
Catalog number 107801 all serial numbers
Where was it sold?
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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
3 other products · FDA event 67639This product is part of a recall event; the main page for the event is HeartMate II System Controller recalled by Thoratec.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | HeartMate II System Controller recalled by Thoratec | Thoratec | Other | Nationwide | |
| CLASS I | Heart Mate II Pocket Controllers removed from packaging recalled | Thoratec | Packaging Defects | Nationwide | |
| CLASS I | HeartMate II Implant Kit with Pocket Controller recalled by Thoratec | Thoratec | Packaging Defects | 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 Heart & Vascular Devices recalls
All 6,268| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |