Reported Sep 23, 2015 · Terminated
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are…
SynCardia Systems Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SynCardia Systems Inc. · 1992 E Silverlake Rd · Tucson, AZ · 85713-3865
Is this the product you have?
- Temporary Total Artificial Heart (TAH-t) with Freedom Driver
- System REF 595000-001 Product UsageFreedom 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
- Lot codes and dates
- Part Number595000-001 Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial #
384 of 384 codes
85979-01385979031479450685979-02285979031479450685977-03385977031333450785976-02085976031041451485976-01085976030944451785976-01485976030944451785979-01485979031479451785979-02185979031479451785976-03985976031074452185977-00185977031074452185978-03485978031823452185978-04085978031823452185977-02085977031333454285977-03285977031333454285979-005859790314524546
- Part Number595000-001 Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial #
- Amount recalled
- 56 drivers (21 currently in use on patients)
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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