Recall record at a glance
| Official record | Z-2731-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | SynCardia Systems Inc. |
| Report date | Sep 23, 2015 |
| Recall initiation date | Aug 6, 2015 |
| Quantity | 56 drivers (21 currently in use on patients) |
| Location | Tucson, AZ, United States |
Official 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.
Why the product was 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.
Distribution information
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 to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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