Zephyr® SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 05414734501606), received between Jun 19, 2018 and Jun 26, 2025 — classified as 4 deaths, 46 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (32 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 90 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS OBSERVED TO BE IN BACKUP VVI MODE DUE TO LOW BATTERY. THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338249 ↗
• InjuryOct 31, 2024Premature Discharge of Battery; Unexpected Mode Switch; Premature Discharge of Battery; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY SEEN ON FEBRUARY 2024 AND THEIR PACEMAKER WAS NOTED TO HAVE APPROXIMATELY 1.75 YEARS OF LONGEVITY REMAINING. DURING AN IN-CLINIC FOLLOW-UP ON OCTOBER 30TH, THE PATIENT'S DEVICE WAS FOUND IN BACKUP VVI. THE BACKUP STATE WAS UNABLE TO BE RECOVERED AS THE BATTERY RESISTANCE WAS 6000 OHMS. PREMATURE DEPLETION WAS SUSPECTED. THE PATIENT'S DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578947 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTIOUS DISEASE. THE ENTIRE SYSTEM WAS REMOVED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 19177925 ↗
• InjuryFeb 12, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE BATTERY HAD DEPLETED PREMATURELY. THE PATIENT WAS IN FOR A ROUTINE FOLLOW-UP AND THE DEVICE SHOWED 1 PLUS YEAR LONGEVITY, AND NEXT FOLLOW-UP 3 MONTHS LATER DEVICE HAD TRIGGERED ERI. THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685371 ↗
• InjuryDec 7, 2023Pacemaker Found in Back-Up Mode; Battery Problem; Pacemaker Found in Back-Up Mode; Battery Problem

  NEW INFORMATION RECEIVED NOTES THAT THE PULSE GENERATOR WAS EXPLANTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18280455 ↗
• MalfunctionJul 24, 2023Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, THAT THE PATIENT PRESENTED IN THE CLINIC. UPON INTERROGATION, IT WAS OBSERVED, THAT THE ELECTROCARDIOGRAM WAS MISSING. FURTHERMORE, THE DEVICE EXHIBITED NOISE. NO INTERVENTION WAS MADE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376835 ↗
• MalfunctionJul 18, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WAS TO RECEIVE AN EMERGENCY REPLACEMENT OF THE PACEMAKER DUE TO THE BATTERY BEING DEAD. THE PACEMAKER HAD BEEN IMPLANTED FOR 8.5 YRS. THE LAST BATTERY VOLTAGE ON (B)(6) 2023 WAS 2.69V AND GETTING CLOSER TO THE ELECTIVE REPLACEMENT INDICATOR (ERI). ON THE (B)(6) 2023 THE BATTERY WAS FOUND DEAD LEADING THE PATIENT TO BE SCHEDULED FOR THE EMERGENCY REPLACEMENT. INFORMATION RECEIVED SUGGESTS A PLAUSIBLE 10 YR WARRANTY REQUEST. A CONFIRMATION THAT THE SCHEDULED REPLACEMENT PROCEDURE HAD OCCURRED WAS REQUESTED BUT WAS NOT YET AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17344352 ↗
• MalfunctionJun 7, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS FOUND TO BE IN BACKUP VVI (BVVI) MODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081206 ↗
• MalfunctionApr 6, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING A ROUTINE FOLLOW-UP IN CLINIC. INTERROGATION SHOWED THE PACEMAKER WAS IN BACKUP VVI (BVVI) MODE. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16697884 ↗
• MalfunctionNov 21, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PROCEDURE. IT WAS NOTED THE PACEMAKER WENT TO BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832310 ↗
• InjuryOct 18, 2022Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. THE DEVICE WAS UNABLE TO BE INTERROGATED; THE PHYSICIAN SUSPECTS PREMATURE BATTERY DEPLETION OF THE PACEMAKER. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PACEMAKER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621227 ↗
• InjurySep 27, 2022Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492096 ↗
• MalfunctionJun 13, 2022Incorrect Measurement; No Pacing; Incorrect Measurement; No Pacing

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON PERFORMING A CAPTURE TEST, THE PATIENT'S PACEMAKER WAS FOUND TO HAVE LOST PACING OUTPUT AND EXHIBITED A DIAGNOSTIC ANOMALY. NO ADDITIONAL INTERVENTION WAS TAKEN AND THE CAPTURE TEST WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676417 ↗
• MalfunctionMay 26, 2022Pacemaker 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 ON (B)(6) 2022. REVIEW OF TRANSMISSIONS REVEALED THAT THE PACEMAKER WAS IN BACKUP VVI MODE. NO PROGRAMMING CHANGES WERE MADE TO THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503933 ↗
• InjuryApr 12, 2022Break; Low impedance; Capturing Problem; Break; Low impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH CAPTURE THRESHOLDS AND LOW IMPEDANCE. AN INSULATION ANOMALY WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087731 ↗
• InjuryMar 9, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE PACEMAKER SHOWED PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713262 ↗
• MalfunctionFeb 24, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. DURING AN INTERROGATION ATTEMPT, IT WAS NOTED THAT THE BATTERY DATA WAS NO LONGER AVAILABLE. AN ADDITIONAL INTERROGATION ATTEMPT WAS PERFORMED AND THE BATTERY DATA WAS UNAVAILABLE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13594136 ↗
• MalfunctionFeb 3, 2022Over-Sensing; Interrogation Problem; Over-Sensing; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED EPISODES OF NOISE. NO INTERVENTION WAS PERFORMED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446665 ↗
• MalfunctionJan 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE PACEMAKER EXHIBITED UNSPECIFIED SENSING ANOMALY AS THE ELECTROGRAM (EGM) READINGS WERE JAGGED. SURFACE ELECTROGRAM WAS PERFORMED TO COMPLETE THE FOLLOW-UP. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES AND PATIENT WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13396363 ↗
• MalfunctionJan 6, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BACKUP MODE. DEVICE REPROGRAMMING WAS NOT POSSIBLE DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177437 ↗
• MalfunctionJan 5, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER'S SET SCREW WOULD NOT TIGHTEN. THE PACEMAKER WAS NOT USED AND A NEW ONE WAS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170395 ↗
• MalfunctionDec 3, 2021No Pacing; No Pacing

  IT WAS REPORTED DURING THE INITIAL IMPLANT PROCEDURE, PATIENT'S NEWLY IMPLANTED PACEMAKER DID NOT PACE. THE PACEMAKER WAS REMOVED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12926915 ↗
• InjuryNov 29, 2021Pacemaker Found in Back-Up Mode; No Pacing; Pacemaker Found in Back-Up Mode; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING MULTIPLE SYNCOPE EVENTS AND SEVERE BRADYCARDIA. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATIONS AND DID NOT PROVIDE ANY PACING. THE PATIENT HAD FELL SEVERAL TIMES DUE TO LACK OF PACING. IT WAS SUSPECTED THAT THE DEVICE REACHED END OF LIFE. THE DEVICE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED. THE PATIENT WAS RECOVERING POST PROCEDURE.

  Patient problems: Arrhythmia; Syncope/Fainting

  MAUDE report 12884715 ↗
• InjuryNov 14, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT'S PACEMAKER (PM) PRESENTED WITH POSSIBLE EARLY BATTERY DEPLETION. THE PM WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808428 ↗
• InjurySep 15, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH A PULSE GENERATOR THAT EXHIBITED BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478720 ↗

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-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-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 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