FORTIFYRecalls & reported problems across all models
St. Jude Medical, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,908
- Deaths reported
- 29
- Injuries reported
- 1,483
- Recalls
- 0
We found 4 models of FORTIFY by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,908 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 17, 2026 — classified as 29 deaths, 1,483 injuries, 396 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (698 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FORTIFY problems
Device problems
- Battery Problem698
- Premature Discharge of Battery422
- Adverse Event Without Identified Device or Use Problem269
- Inappropriate/Inadequate Shock/Stimulation198
- Inappropriate or Unexpected Reset138
- Failure to Interrogate132
- Over-Sensing106
- Incorrect Interpretation of Signal74
Patient problems
- No Known Impact Or Consequence To Patient982
- No Clinical Signs, Symptoms or Conditions450
- Therapeutic Effects, Unexpected142
- Unspecified Infection112
- No Consequences Or Impact To Patient82
- Discomfort57
- Insufficient Information52
- No Information31
FORTIFY models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FORTIFY™ CD2231-40QPulse generator, permanent, implantable15 deaths623 reports
- FORTIFY™ CD1231-40QPulse generator, permanent, implantable3 deaths618 reports
- FORTIFY™ CD2231-40Pulse generator, permanent, implantable4 deaths334 reports
- FORTIFY™ CD1231-40Pulse generator, permanent, implantable7 deaths333 reports
Recent FORTIFY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812237 ↗InjuryJun 15, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25511006 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD WAS EXPLANTED DUE TO INFECTION. THE PATIENT WAS DISCHARGED WITH NO REPORTS OF ADVERSE CONSEQUENCES.
Patient problems: Unspecified Infection
MAUDE report 25028752 ↗InjuryApr 28, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL EXPERIENCING DISCOMFORT. UPON REVIEW, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCORRECT INTERPRETATION OF SIGNAL RESULTING IN THE DELIVERY OF INAPPROPRIATE SHOCKS. THE ICD AND RV LEAD WAS REPROGRAMMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Discomfort
MAUDE report 25017572 ↗MalfunctionApr 15, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO BE IN BACKUP OPERATION DUE TO PATIENT HAVING AN MRI EXAMINATION. PROGRAMMING CHANGES WERE PERFORMED TO RESTORE THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887966 ↗MalfunctionApr 6, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Compatibility Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24795329 ↗InjuryMar 17, 2026Premature Discharge of Battery; Failure to Charge; Failure to Convert Rhythm; Inappropriate or Unexpected Reset
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE PATIENT HAD EXPERIENCED VENTRICULAR TACHYCARDIA (VT) BUT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILED TO PROVIDE EFFECTIVE TREATMENT. IT WAS DISCOVERED THAT THE DEVICE WAS IN BACKUP MODE. DATA ANALYSIS REVEALED THAT THE DEVICE HAD MULTIPLE FAILED CHARGING ATTEMPTS. IT WAS SPECULATED THAT THE CAPACITOR OVERLOAD CAUSED THE ICD TO BE UNABLE TO COMPLETE THE CHARGING PROCESS, AND MULTIPLE CHARGING ATTEMPTS LED TO BATTERY DEPLETION. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Arrhythmia
MAUDE report 24622059 ↗InjuryMar 9, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP VVI MODE DUE TO PREMATURE BATTERY DEPLETION, RESULTING IN A LOSS OF HIGH VOLTAGE THERAPIES. THE ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED, AND THE PATIENT REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551518 ↗InjuryFeb 23, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION DURING DEVICE INTERROGATION. A FOLLOW-UP INTERROGATION REVEALED THAT THE ICD ENTERED BACKUP VVI MODE, WHICH CAUSED THE PATIENT DISCOMFORT DUE TO THE VIBRATION ALERTS. PROGRAMMING CHANGES WERE MADE, AND THE ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 24421650 ↗MalfunctionFeb 17, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369366 ↗DeathJan 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DIED DUE TO CARDIOPULMONARY ARREST. IT IS UNKNOWN WHETHER THE PATIENT'S CAUSE OF DEATH IS DEVICE OR PROCEDURE RELATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24182606 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH REDNESS, DISCHARGE AND INFECTION AT DEVICE POCKET. THE WOUND HAS NOT HEALED PROPERLY. THE INFECTION WAS NOT ASSOCIATED WITH ANY ABBOTT PRODUCT AND/OR PROCEDURE. THE HIGH VOLTAGE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence
MAUDE report 24000309 ↗MalfunctionDec 29, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED DUE TO THE PATIENT UNDERGOING A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. THE ICD WAS NOT MRI COMPATIBLE AND WAS NOT PUT INTO MRI MODE PRIOR TO PROCEDURE. PROGRAMMING CHANGES WERE MADE TO RESET THE DEVICE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917111 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED LESS THAN A MONTH AFTER IMPLANT AT A FOLLOW UP VISIT THAT AN ABSCESS WAS PRESENT IN THE WOUND. THE WOUND WAS RED, SWOLLEN BUT NOT OPEN. THE CLINICIAN EXPLANTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD. A RE-IMPLANT WAS TO BE PERFORMED ON THE OPPOSING SIDE AT A LATER DATE. THE PATIENT WAS STABLE.
Patient problems: Unspecified Infection
MAUDE report 23752364 ↗MalfunctionDec 8, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION DUE TO SUSPECTED RADIOFREQUENCY ABLATION. PROGRAMMING CHANGES WERE MADE TO RESET THE DEVICE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744157 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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