Zephyr® DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 05414734501613), received between Jun 12, 2018 and Apr 23, 2026 — classified as 9 deaths, 133 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (78 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 219 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Pacing Problem

  IT WAS REPORTED THAT DURING THE STANDARD GENERATOR CHANGEOUT PROCEDURE, THE PATIENT EXPERIENCED AN ARRHYTHMIA AND A LOSS OF LOW VOLTAGE (LV) OUTPUT DUE TO ELECTROCAUTERY. THE PATIENT'S PACEMAKER WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 24971489 ↗
• DeathJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CARDIOPULMONARY ARREST. THE PATIENT'S PACEMAKER, RIGHT VENTRICULAR (RV) LEAD, AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED. IT IS UNKNOWN IF THE PATIENT'S PRODUCTS OR PROCEDURE CONTRIBUTED TO THEIR DEATH.

  Patient problems: Insufficient Information

  MAUDE report 24203555 ↗
• MalfunctionMar 27, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PACEMAKER THAT WAS UNABLE TO BE INTERROGATED. NO INTERVENTION WAS PERFORMED. PATIENT STATUS WAS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21704979 ↗
• MalfunctionDec 13, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PACEMAKER WAS IN BACKUP VVI MODE. NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922532 ↗
• MalfunctionOct 11, 2024Failure to Interrogate; Data Problem; Failure to Interrogate; Data Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FOR SCHEDULED PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT PACEMAKER COULD NOT BE INTERROGATED DUE TO A CONNECTION ERROR. THE PACEMAKER WAS ULTIMATELY NOT USED AND REPLACED WITH NEW ONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425669 ↗
• InjurySep 24, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT PATIENT ATTENDED TO CLINIC FOR FOLLOW UP. THE PATIENT'S PACEMAKER (PM) FAILED TO BE INTERROGATED. THE PM WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THE PATIENT HAD NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294975 ↗
• DeathApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. THE DEATH WAS REPORTED WITHOUT CLEAR INFORMATION AS TO WHETHER THE DEATH WAS DEVICE RELATED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173769 ↗
• InjuryApr 23, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED, THAT THE PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS NOTED, THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING PREMATURE DISCHARGE OF BATTERY. THE ICD WAS EXPLANTED AND NEW ICD WAS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169545 ↗
• MalfunctionApr 4, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT A PULSE GENERATOR HAD DISPLAYED ERROR MESSAGE DURING PREPARATION FOR AN IMPLANT. THE PULSE GENERATOR WAS NOT USED, AND A NEW PULSE GENERATOR WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039117 ↗
• InjuryMar 6, 2024Premature Discharge of Battery; Failure to Interrogate; Pacemaker Found in Back-Up Mode; Unexpected Mode Switch; Premature Discharge of Battery; Failure to Interrogate; Pacemaker Found in Back-Up Mode; Unexpected Mode Switch

  IT WAS REPORTED THAT DURING A DEVICE CHECK, A SLOW HEART RATE WAS OBSERVED ON THE ELECTROGRAM (EGM). WHEN INITIAL DEVICE INTERROGATION WAS ATTEMPTED, NO COMMUNICATION COULD BE ESTABLISHED, BUT AFTER A FEW ATTEMPTS INTERROGATION WAS ACHIEVED. THE DEVICE WAS FOUND TO BE IN BACKUP MODE. A PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Arrhythmia

  MAUDE report 18851180 ↗
• InjuryJan 3, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL FASTER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436375 ↗
• InjuryDec 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325770 ↗
• InjuryDec 8, 2023Premature Discharge of Battery; Pacing Problem; Premature Discharge of Battery; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION, OUTPUT RATE ISSUE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297641 ↗
• MalfunctionNov 21, 2023Pacing Problem; Pacing Problem

  NEW INFORMATION RECEIVED NOTES THE PATIENT DID NOT CONTACT HER CLINIC IN (B)(6) 2023 REGARDING POTENTIAL SYMPTOMS OR ISSUES WITH THE PACEMAKER. THE PATIENT WAS INTERROGATED IN (B)(6) 2023 DURING A FOLLOW UP IN CLINIC AND THE PACEMAKER WAS FOUND TO HAVE REACHED THE NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THERE WERE NO COMPLAINTS OR ISSUES REPORTED BY THE PATIENT DURING HER VISIT IN CLINIC IN (B)(6) 2023. THE PATIENT RECEIVED A ROUTINE CHANGEOUT DUE TO NORMAL ERI ON (B)(6) 2024 WHICH WAS SUCCESSFUL. THE PATIENT HAD A FOLLOW UP ON (B)(6) 2024 AND WAS DOING WELL WITH NO COMPLAINTS.

  Patient problems: Fatigue

  MAUDE report 18188551 ↗
• MalfunctionNov 10, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED A PATIENT'S PACEMAKER PRESENTED WITH PREMATURE BATTERY DEPLETION. NO CHANGES WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112633 ↗
• InjurySep 7, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE. PRIOR TO THE PROCEDURE, THE PACEMAKER WAS INTERROGATED, AND IT WAS NOTED THAT THE PACEMAKER WAS IN BACK-UP VVI MODE. THE DEVICE WAS UNABLE TO BE RESTORED TO THE ORIGINAL SETTINGS. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17705405 ↗
• MalfunctionAug 16, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE IN-CLINIC FOLLOW-UP. INTERROGATION OF THE PULSE GENERATOR REVEALED THAT THE DEVICE WAS IN BACKUP OPERATION. IT WAS SUSPECTED THAT BACKUP RESULTED FROM NORMAL BATTERY DEPLETION AS THE GENERATOR HAD TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS NOT PACING DEPENDENT, AND NO INTERVENTIONS WERE REPORTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561204 ↗
• MalfunctionAug 15, 2023Loose or Intermittent Connection; No Pacing; Loose or Intermittent Connection; No Pacing

  IT WAS REPORTED THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING SURGERY, IT WAS DISCOVERED THE PACEMAKER EXHIBITED NO PACING OUTPUT AND THE ATRIAL SET SCREW COULD NOT BE TIGHTENED. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITH A DIFFERENT PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553239 ↗
• InjuryApr 11, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THE PATIENT PRESENTED PRIOR TO A GENERATOR CHANGE OUT. DURING INTERROGATION BEFORE THE SURGERY, THE PACEMAKER WAS UNABLE TO RUN THE RIGHT VENTRICULAR CAPTURE THRESHOLD TEST DUE TO A TELEMETRY PROBLEM. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16720231 ↗
• InjuryApr 6, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON REVIEW, THE PACEMAKER EXHIBITED PREMATURE BATTERY DISCHARGE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691550 ↗
• MalfunctionFeb 2, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP CHECK AFTER THE PATIENT EXPERIENCED THEIR HEART BEAT HARDER THAN USUAL. UPON REVIEW, THE PACEMAKER WAS FOUND TO BE IN THE BACK-UP MODE. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283861 ↗
• InjuryJan 27, 2023Premature Discharge of Battery; Failure to Interrogate; Pacemaker Found in Back-Up Mode; No Pacing; Premature Discharge of Battery; Failure to Interrogate; Pacemaker Found in Back-Up Mode; No Pacing

  DURING AN IN CLINIC FOLLOW UP, IT WAS NOTED THE DEVICE WAS FOUND IN BACK UP MODE AND UNABLE TO BE INTERROGATED. TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED THE BATTERY WAS DRAINED. A MAGNET WAS ATTEMPTED AND THERE WAS NO RESPONSE FROM THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255394 ↗
• MalfunctionDec 22, 2022Battery Problem; Battery Problem

  IT WAS REPORTED DURING IMPLANT PROCEDURE THAT THE PACEMAKER EXHIBITED HIGH BATTERY RESISTANCE. THE DEVICE WAS SUCCESSFULLY EXCHANGED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035949 ↗
• MalfunctionNov 4, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THE DEVICE WAS IN BACK UP MODE. TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED THE BACK UP MODE WAS DUE TO THE DEVICE BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE ERI TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731797 ↗
• InjuryOct 16, 2022Failure to Interrogate; Pacemaker Found in Back-Up Mode; Failure to Interrogate; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE. PRIOR TO THE PROCEDURE, THE PACEMAKER FAILED TO BE INTERROGATED AND WENT TO BACKUP VVI MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

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

  MAUDE report 15613166 ↗

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-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• 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-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-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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator