SynCardia Freedom® Driver 595000-001Recalls & reported problems
Syncardia Systems, LLC · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This SynCardia Freedom Driver for an artificial heart has 756 reports, with 7 deaths and 34 injuries. Many reports describe alarm and message problems, such as incorrect messages on the display and unclear audible prompts, and many say the patient had no consequences. A recall that started in October 2016 is closed; it concerns drivers whose main circuit board can fail and stop the unit without warning, which could end life-sustaining support.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 809
- Deaths reported
- 7
- Injuries reported
- 35
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 809 adverse event reports that list this exact device (DI 00858000003121), received between Apr 6, 2016 and Sep 30, 2026 — classified as 7 deaths, 35 injuries, 767 malfunctions.
The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (389 reports).
1 FDA recall record name this device's identifier.
4 other recalls cover devices cleared under the same FDA submission (P030011); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 21, 2016Class ITerminated
The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.
Z-0659-2017 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Audible Prompt/Feedback Problem389
- Device Displays Incorrect Message181
- Output Problem75
- Mechanical Problem66
- No Apparent Adverse Event62
- Noise, Audible56
- Electrical /Electronic Property Problem40
- Device Operates Differently Than Expected34
Patient problems
- No Consequences Or Impact To Patient342
- No Clinical Signs, Symptoms or Conditions332
- No Known Impact Or Consequence To Patient169
- No Patient Involvement116
- Loss of consciousness31
- Patient Problem/Medical Problem10
- High Blood Pressure/ Hypertension9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
Recent adverse event reports
The 25 most recent of 809 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955146 ↗MalfunctionSep 30, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955144 ↗MalfunctionSep 30, 2026Audible Prompt/Feedback Problem
Per hospital staff, patient called with unresolvable fault alarm. States fault alarm started after receiving a "3 beep" intermittent battery alarm, replaced a battery with a new one and driver immediately started fault alarming. Changed 2nd battery and alarm continued. No changes to TAH parameters. States new batteries placed into freedom driver were fully charged. Patient switched driver without any reported adverse impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948642 ↗MalfunctionSep 30, 2026Audible Prompt/Feedback Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50948640 ↗MalfunctionSep 25, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902885 ↗MalfunctionSep 24, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891853 ↗MalfunctionSep 24, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891852 ↗MalfunctionSep 24, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891847 ↗MalfunctionSep 24, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891846 ↗MalfunctionSep 24, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885398 ↗MalfunctionSep 24, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885397 ↗MalfunctionSep 24, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885388 ↗MalfunctionSep 23, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874122 ↗MalfunctionSep 22, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862842 ↗MalfunctionSep 22, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862839 ↗MalfunctionSep 22, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862816 ↗MalfunctionSep 22, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862815 ↗MalfunctionSep 22, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862810 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849129 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849128 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849126 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849125 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847265 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846184 ↗MalfunctionSep 21, 2026Audible Prompt/Feedback Problem
Per hospital staff, Freedom Driver experienced an out of box system failure with red alarms that could not be resolved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843208 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P030011. One submission often covers many models, so check the product and lot details in each record.
- Z-0126-2024 · Aug 1, 2023 · CompletedSynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Z-1022-2023 · Nov 2, 2022 · Open, ClassifiedSynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
- Z-2731-2015 · Aug 6, 2015 · TerminatedTemporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Hear
- Z-0620-2013 · Dec 5, 2012 · TerminatedCompanion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Sys
Other Artificial Heart devices
- SynCardia Companion 2 Driver 397002-001Syncardia Systems, LLC · Artificial Heart2 deaths414 reports
- SynCardia temporary Total Artificial Heart System 500101-001Syncardia Systems, LLC · Artificial Heart141 deaths215 reports
- SynCardia Freedom® Onboard Battery 295025-001Syncardia Systems, LLC · Artificial Heart62 reports
- SynCardia 50cc TAH-t, Clinical 570500-001Syncardia Systems, LLC · Artificial Heart1 recall5 deaths5 reports
- SynCardia Companion Hospital Cart 397003-001Syncardia Systems, LLC · Artificial Heart9 reports
- SynCardia Companion Rechargeable LI-ION Battery 293001-001Syncardia Systems, LLC · Artificial Heart8 reports
- SynCardia Companion Driver Caddy 397001-001Syncardia Systems, LLC · Artificial Heart3 reports
- SynCardia Hand Pump 397004-001Syncardia Systems, LLC · Artificial Heart2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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