Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 23, 2015
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the lo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
SynCardia Systems Inc. recalled Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 … - a critical-severity action.
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 … was recalled by SynCardia Systems Inc. in September 23, 2015. Reason: SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may f…. Check the official notice for the remedy. Verify recall #Z-2731-2015 with the FDA Devices before acting.
The recall
SynCardia Systems Inc. issued this critical-severity FDA Devices recall-SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may f….
- Critical
- severity level
- Class I
- classification
- September 23, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2731-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2731-2015) was formally reported on September 23, 2015, with the manufacturer initiating the action on August 6, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. SynCardia Systems Inc. is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as 56 drivers (21 currently in use on patients).
The documented reason for this recall is: SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function. Distribution data in the federal record shows the product reached: Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
56 drivers (21 currently in use on patients)
Related Recalls
6
3 from same agency
Product description
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
Reason for recall
SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2731-2015 |
| Date reported | September 23, 2015 |
| Date initiated | August 6, 2015 |
| Recalling firm | SynCardia Systems Inc. |
| Firm location | Tucson, AZ |
| Affected scope | 56 drivers (21 currently in use on patients) |
| Distribution | Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France. |
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-2731-2015) 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.
Frequently Asked Questions
What product was recalled? ▼
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.. Recalled by SynCardia Systems Inc.. Units affected: 56 drivers (21 currently in use on patients).
Why was this product recalled? ▼
SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2015. Severity: Critical. Recall number: Z-2731-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2731-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 23, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.