FDA Devices recall · Reported May 31, 2017
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
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 eas…
Thoratec Corporation recalled HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:0… - a critical-severity action.
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:0… was recalled by Thoratec Corporation in May 31, 2017. Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software a…. Check the official notice for the remedy. Verify recall #Z-2051-2017 with the FDA Devices before acting.
The recall
Thoratec Corporation issued this critical-severity FDA Devices recall-St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software a….
- Critical
- severity level
- Class I
- classification
- May 31, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2051-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2051-2017 |
| Date reported | May 31, 2017 |
| Date initiated | March 30, 2017 |
| Recalling firm | Thoratec Corporation |
| Firm location | Pleasanton, CA |
| Affected scope | 24,077 active units in US |
| Distribution | 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, Kazakhs… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2051-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026