Accent® DR RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,370 adverse event reports that list this exact device (DI 05414734503617), received between Jun 11, 2018 and Sep 10, 2026 — classified as 73 deaths, 496 injuries, 801 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (218 reports).

9 other recalls cover devices cleared under the same FDA submission (P880086); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,370 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Low impedance

  It was reported that the patient presented to the clinic for follow-up. Low pacing impedance measurements were observed while the pacemaker (PM) was at the normal elective replacement indicator (ERI) stage. Consequently, the PM was explanted and replaced with a new PM on (b)(6)2026. The existing atrial and right ventricle (RV) leads were retained and successfully reconnected to the newly implanted PM. Subsequent Pacing System Analyzer (PSA) testing and lead impedance measurements performed after reconnection to the replacement PM were within normal limits, indicating acceptable lead impedance measurements with both the explanted and replacement PMs. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50706609 ↗
• InjuryJun 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE CHEST PAIN. IT WAS NOTED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Discomfort

  MAUDE report 25673792 ↗
• InjuryJun 9, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGES PROCEDURE. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER, RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. THE PACEMAKER WAS EXPLANTED. THE RA AND RV LEADS WAS STILL IMPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452124 ↗
• MalfunctionJun 2, 2026Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS BEEPING EVERY FEW SECONDS WITHOUT STOPPING. NO INTERVENTIONS OR CHANGES WERE PERFORMED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368772 ↗
• MalfunctionMay 24, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER HAD ENTERED BACK-UP VVI MODE. THE PACEMAKER WAS RESTORED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267304 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED NOISE EPISODES. THE INTERVENTION AND PATIENT CONDITION WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25229281 ↗
• MalfunctionApr 27, 2026Signal Artifact/Noise; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT THE PACEMAKER EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE NOISE ISSUE WAS OBSERVED YEARS AGO, AND THE CLINIC WAS MONITORING THE PACEMAKER. NO INTERVENTIONS OR CHANGES WERE PERFORMED, AND THE PACEMAKER WILL CONTINUE TO BE MONITORED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010183 ↗
• MalfunctionMar 30, 2026Failure to Interrogate; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER COULD NOT BE INTERROGATED. NO INTERVENTION WAS REPORTED. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718104 ↗
• MalfunctionMar 10, 2026Inappropriate or Unexpected Reset; Unexpected Mode Switch

  IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT PACEMAKER WAS IN BACK-UP MODE AND THE DEVICE STATUS REPORT DISPLAYED DASHES, WITH BATTERY VOLTAGE AND ESTIMATED LONGEVITY UNAVAILABLE. THE CLINIC ATTEMPTED A BACKUP RESTORATION, BUT THE DOWNLOAD FAILED, LIKELY DUE TO LOW BATTERY STATUS. NO OTHER INTERVENTION WAS REPORTED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561375 ↗
• InjuryFeb 4, 2026Failure to Capture; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A METAL ALLERGY AND THEIR PACEMAKER EXHIBITED A FAILURE TO PACE AND SENSE. THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24260780 ↗
• MalfunctionDec 11, 2025Loose or Intermittent Connection; Failure to Disconnect; Contamination of Device Ingredient or Reagent; Loose or Intermittent Connection; Failure to Disconnect; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE OUT PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER'S ATRIAL SET SCREW COULD NOT BE ENGAGED WITH THE WRENCH. SOME SORT OF HARD BUILD UP WAS NOTED ON THE SET SCREW SLOT. THE ATRIAL LEAD COULD NOT BE SEPARATED SO IT WAS CUT AND CAPPED. THE DEVICE AND LEAD WERE THEN SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779738 ↗
• InjuryNov 26, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DEVICE ANOMALY WAS OBSERVED ON A PATIENT'S PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661125 ↗
• MalfunctionNov 20, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ELECTROCARDIOGRAM ANOMALY NOTED ON THE PATIENT'S PACEMAKER. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613080 ↗
• MalfunctionSep 8, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED DURING AN IN-CLINIC FOLLOW-UP. DURING THE LAST FOLLOW-UP CHECK IN (B)(6) 2025, THE DEVICE REPORTED 7.5 MONTHS TO 10.5 MONTHS REMAINING, AND UNEXPECTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE DID NOT RESPOND TO MAGNET PLACEMENT. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992991 ↗
• InjuryJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS EXPLANTED DUE TO AN UNKNOWN REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181939 ↗
• InjuryMay 6, 2025Failure to Capture; Low impedance; Failure to Capture; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED LOW PACING IMPEDANCE AND FAILURE TO CAPTURE. THE PHYSICIAN EXPLANTED AND REPLACED THE PACEMAKER TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965918 ↗
• InjuryApr 21, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE CHECK-UP, BUT IT WAS NOTED THAT THE PACEMAKER FAILED TO BE INTERROGATED THROUGH INDUCTIVE TELEMETRY. AS A RESOLUTION THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876005 ↗
• MalfunctionFeb 24, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW UP. INTERROGATION SHOWED THE PATIENT'S PACEMAKER WAS IN BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442936 ↗
• InjuryFeb 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA PRODUCT RECEIPT THAT THE PACEMAKER WAS EXPLANTED AND REPLACED DUE TO UNSPECIFIED FAILURE. FURTHER INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21441925 ↗
• MalfunctionFeb 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A GENERATOR CHANGEOUT PROCEDURE, IT WAS NOTED THAT THE SET SCREW OF THE PACEMAKER VENTRICULAR PORT WAS STRIPPED. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418524 ↗
• MalfunctionFeb 20, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED AN UNSPECIFIED OVERSENSING. NO INTERVENTION OR PATIENT CONDITION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418245 ↗
• MalfunctionJan 5, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PACEMAKER IN BACK-UP MODE. NO PATIENT SYMPTOMS OR INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075736 ↗
• InjuryNov 19, 2024Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  IT WAS REPORTED THAT PATIENT PRESENTED FOR GENERATOR REPLACEMENT PROCEDURE ON (B)(6) 2024, THE SET SCREW OF THE PACEMAKER (PM) WAS FOUND STRIPPED AND THE ATRIAL LEAD FAILED TO BE REMOVED FROM THE HEADER. THE REMOVAL OF THE PM AND ATRIAL LEAD WAS NOT SUCCESSFUL. ON (B)(6) 2024, THE PHYSICIAN ELECTED TO BREAK THE LEAD AND REPLACED WITH A NEW LEAD. ADDITIONALLY, THE PM WAS CONCURRENTLY REPLACED WITH A NEW PM. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20720441 ↗
• InjuryNov 13, 2024Capturing Problem; Migration; Capturing Problem; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4), RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED, THAT THE PACEMAKER EXHIBITED CAPTURE ANOMALY. AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING. RESULTING, IN INAPPROPRIATE MODE SWITCH. THE PHYSICIAN BELIEVES THAT THE RA LEAD NOISE WAS, DUE TO THE INSULATION BREAK CLOSE TO THE SUTURE SLEEVE THAT WAS NOTED, DURING THE PROCEDURE. ADDITIONALLY, THE PATIENT WAS NOTED, TO HAS TWIDDLED THE PACEMAKER, RA LEAD AND RIGHT VENTRICULAR (RV) LEAD. THE PACEMAKER WAS EXPLANTED, WHILE THE RA AND RV LEADS WERE REVISED ON (B)(6) 2024 AND REMAINED IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679501 ↗
• InjuryNov 12, 2024High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED PROCEDURE. THE PATIENT'S PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH IMPEDANCE MEASUREMENT. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20661304 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.

• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator