Device recall: Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are…
Class I FDA enforcement event 71905. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
SynCardia Systems Inc. started this device recall on 6 Aug 2015. The firm address in the FDA record is in Tucson, AZ. FDA put the recall in Class I. FDA event 71905 has 1 product record. The first FDA enforcement report date is 23 Sep 2015. The record gives the status Terminated, with the termination date 4 Nov 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
SynCardia Systems Inc., Tucson, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2731-2015 | 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… | 56 drivers (21 currently in use on patients) | Class I | Terminated | 23 Sep 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class I
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Oct 2016 | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 | Device | Class I | 1 |
| 5 Dec 2012 | Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Dri | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2731-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 71905. https://recallregister.com/fda/i/71905/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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.
- What quantity of product is in FDA event 71905?
- The FDA record gives this quantity:
56 drivers (21 currently in use on patients)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 4% of the 1,153 device events that started in 2015 are in Class I.