CLASS I Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
HeartMate II Implant Kit with Pocket Controller recalled by Thoratec
Thoratec is recalling HeartMate II Implant Kit with Pocket Controller, 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-1227-2014
- 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
- Packaging Defects
- Device type
- Other Medical 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) 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 106015 (NAm) 106016 - EU 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 | HeartMate II LVAD Pump and Pock Controller Kit recalled by Thoratec | Thoratec | Other | Nationwide | |
| CLASS I | Heart Mate II Pocket Controllers removed from packaging recalled | 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 Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |