CLASS I Device recall · Reported 31 May 2017 · FDA Enforcement Report
HeartMate¿ II LVAS with Pocket Controller recalled by Thoratec
Thoratec is recalling HeartMate¿ II LVAS with Pocket Controller. The recall was initiated on 30 Mar 2017 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-2052-2017
- FDA event ID
- 76978
- Recalling firm
- Thoratec, Pleasanton, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Mar 2017
- FDA classified
- 24 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 30 Mar 2017 | Recall initiated by company | |
| 24 May 2017 | Classified by FDA | +55 days |
| 31 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
Where it was distributed
Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Questions about this recall
Why was it recalled?
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Which lots are affected?
Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.
Where was it sold?
Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, 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
1 other product · FDA event 76978This product is part of a recall event; the main page for the event is HeartMate¿ II LVAS with Pocket Controller recalled by Thoratec.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | HeartMate¿ II LVAS with Pocket Controller recalled by Thoratec | Thoratec | Device Malfunction | CA |
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 |
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| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |