Gallant™ CDDRA500TRecalls & reported problems
St. Jude Medical, Inc. · DR Implantable Cardioverter Defibrillator · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Gallant implantable cardioverter defibrillator is a heart device implanted under the skin to monitor and shock abnormal rhythms. Most of the 45 reports describe the device picking up signals it shouldn't, failing to read its own data, and loose connections at the lead, plus a few shocks delivered when none were needed. Patients reported bleeding or infection at the implant site. There are no deaths and 10 injuries. No recalls name this device.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05415067049476), received between Oct 11, 2024 and Sep 29, 2026 — classified as 11 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (13 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing13
- Failure to Interrogate9
- Loose or Intermittent Connection8
- Adverse Event Without Identified Device or Use Problem6
- Under-Sensing4
- Inappropriate/Inadequate Shock/Stimulation3
- High impedance2
- Incorrect Interpretation of Signal2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Unspecified Infection4
- Insufficient Information2
- Pocket Erosion2
- Arrhythmia1
- Discomfort1
- Hematoma1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Component Missing
It was reported that, during an implant procedure, the Implantable Cardioverter Defibrillator (ICD) was found to be missing a set screw. The ICD was not used, and the physician elected to use another ICD. The patient's condition remained stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934842 ↗MalfunctionSep 15, 2026Over-Sensing
It was reported that the patient presented remotely. A remote transmission showed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited myopotential oversensing. No intervention was performed. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778352 ↗MalfunctionSep 11, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743242 ↗MalfunctionSep 3, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589095 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with a pocket infection. The physician explanted the entire system, including the implantable cardioverter-defibrillator (ICD), right ventricular (RV) lead and right atrial (RA) lead. A new ICD, RV lead and RA lead were implanted on (b)(6) 2026. The patient remained in stable condition.
Patient problems: Unspecified Infection
MAUDE report 50535509 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient exhibited a pocket hematoma. The physician explanted the device. The patient condition was stable.
Patient problems: Hematoma
MAUDE report 50525739 ↗InjuryJul 8, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MISINTERPRETED SUPRAVENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT) AND DELIVERED AN INAPPROPRIATE SHOCK. PROGRAMMING CHANGES WERE MADE, AND THE PATIENT¿S CONDITION WAS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749330 ↗MalfunctionJun 9, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVER-SENSING ISSUE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450000 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT IN THE CLINIC WITH A POCKET INFECTION. REDNESS AND SWELLING OF THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) POCKET WERE NOTED. THE INFECTION WAS CONSIDERED PROCEDURE-RELATED. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM, INCLUDING THE ICD, THE RIGHT ATRIAL (RA) LEAD, THE RIGHT VENTRICULAR (RV) LEAD, AND THE OLD CAPPED RA LEAD. A NEW ICD, RA LEAD, AND RV LEAD WERE IMPLANTED ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 25439361 ↗MalfunctionMay 22, 2026Loose or Intermittent Connection
DURING A DEVICE EXCHANGE WHILE TIGHTENING THE SET SCREWS ON THE HEADER OF THE DEVICE, THE SET SCREWS APPEARED TO BE STRIPPED. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255360 ↗MalfunctionMay 1, 2026Intermittent Capture
IT WAS REPORTED VIA A REVIEW OF REMOTE TRANSMISSION THAT THE DEVICE EXHIBITED SEVERAL EPISODES OF NON-SUSTAINED VENTRICULAR OVERSENSING DUE TO INTERMITTENT VENTRICULAR CAPTURE. THE PATIENT PRESENTED TO THE CLINIC, AND NO CHANGES WERE MADE AT THIS TIME. THE PATIENT WAS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061821 ↗MalfunctionApr 11, 2026High impedance; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, HIGH PACING IMPEDANCE WAS OBSERVED ON THE DEVICE. THE PHYSICIAN DISCONNECTED AND RECONNECTED THE RIGHT VENTRICULAR LEAD, BUT THIS ISSUE REMAINED. THE LEAD WAS TESTED WITH A PACING SYSTEM ANALYZER, AND THE IMPEDANCE MEASUREMENT WAS NORMAL. THE SET SCREW WAS NO LONGER ABLE TO BE TIGHTENED WHILE CONNECTING THE LEAD TO THE DEVICE FOR A THIRD TIME. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847107 ↗InjuryApr 8, 2026Failure to Convert Rhythm
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH VENTRICULAR TACHYCARDIA (VT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD FAILED TO CONVERT THE PATIENT¿S RHYTHM AND EXTERNAL DEFIBRILLATION WAS USED. DEVICE INTERROGATION REVEALED THAT THE RV LEAD HAD FAILED TO CAPTURE. ON (B)(6) 2026, THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD. DURING THIS PROCEDURE, FLUOROSCOPY WAS PERFORMED NOTING INSULATION BREAKS ON THE RIGHT ATRIAL (RA) LEAD. NO ANOMALIES WERE NOTED ON THE RV LEAD VIA FLUOROSCOPY. ADDITIONALLY, RA LEAD NOISE WAS NOTED DURING MANIPULATION. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RA LEAD DURING THE SAME PROCEDURE. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: Arrhythmia
MAUDE report 24824002 ↗MalfunctionMar 25, 2026Over-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689410 ↗MalfunctionMar 24, 2026Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THE ICD WAS LATER OBSERVED TO BE CONNECTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675361 ↗MalfunctionMar 17, 2026Failure to Interrogate
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24623893 ↗MalfunctionMar 13, 2026Over-Sensing
IT WAS REPORTED THAT MYOPOTENTIAL OVERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24595665 ↗MalfunctionMar 11, 2026Under-Sensing
NEW INFORMATION RECEIVED NOTED THAT PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24569402 ↗InjuryMar 6, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE DEVICE DELIVERED AN INAPPROPRIATE THERAPY. NO INTERVENTION WAS PERFORMED, AND NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24537367 ↗MalfunctionFeb 24, 2026Loose or Intermittent Connection
DURING THE INITIAL IMPLANT PROCEDURE, THE SET SCREW WAS UNABLE TO BE TIGHTENED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438686 ↗MalfunctionFeb 18, 2026Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381111 ↗MalfunctionFeb 2, 2026Incorrect Interpretation of Signal
NEW INFORMATION RECEIVED NOTES THE PATIENT CAME INTO CLINIC FOR A DEVICE CHECK AND PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24241093 ↗MalfunctionJan 5, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A DEVICE CHANGEOUT PROCEDURE. DURING THE PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)'S SET SCREW HAD A LOOSE CONNECTION AND WOULD NOT LOCK INTO PLACE. IT WAS UNABLE TO BE IMPLANTED ON (B)(6) 2025, AND THE ICD WAS SUCCESSFULLY REPLACED. THE PATIENT REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960566 ↗MalfunctionDec 2, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S SET SCREW WAS TOO LOOSE AND UNABLE TO BE TIGHTENED. THE DEVICE WAS SUCCESSFULLY REPLACED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696190 ↗MalfunctionNov 26, 2025Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH SENSING. PROGRAMMING CHANGES WERE MADE, BUT IT CAUSED THE ICD TO EXHIBIT UNDERSENSING. ADDITIONAL PROGRAMMING CHANGES WERE MADE TO RESOLVE THE EVENT. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660354 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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