Zephyr™ XL SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 05414734501712), received between Jun 17, 2018 and Sep 3, 2026 — classified as 2 deaths, 78 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (35 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 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596912 ↗
• MalfunctionAug 13, 2026Failure to Interrogate

  Additional information was received that the device was explanted and replaced to resolve event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242042 ↗
• MalfunctionJul 13, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS FOUND IN BACKUP VVI. A DEVICE RESTORATION WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25795309 ↗
• MalfunctionApr 17, 2026Break; Pacing Problem

  IT WAS REPORTED THAT PACEMAKER (PM) WAS AT NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) AND DURING THE PM CHANGE PROCEDURE, THE PM HAD FULLY DIED DUE TO CAUTERY SHORT CIRCUITED OF THE BATTERY. THE PM WAS EXPLANTED AND REPLACED ON (B)(6) 2026. NO PATIENT SYMPTOM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24908532 ↗
• InjuryMar 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706594 ↗
• InjuryMar 26, 2026Computer Operating System Problem; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT IN CLINIC WITH AN INCREASED HEART RATE. IT WAS NOTED THAT THE PATIENT¿S PACEMAKER EXHIBITED A BACKUP VVI MODE. REPROGRAMMING WAS ATTEMPTED BUT FAILED DUE TO CORRUPTED PACEMAKER¿S PROGRAM. THERE WERE NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 24695661 ↗
• MalfunctionFeb 5, 2026Loose or Intermittent Connection; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOLLOWING DAY AFTER IMPLANTATION, ON (B)(6) 2026, THAT THERE WAS HIGH CAPTURE THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. ON (B)(6) 2026, IMAGING WAS PERFORMED AND REVEALED THAT THE RV LEAD HAD DISLODGED. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO REPOSITION THE RV LEAD. DURING THE PROCEDURE, IT WAS NOTED THAT THE SET SCREW OF THE PACEMAKER (PM) WAS UNABLE TO BE TIGHTENED AND AFTER MULTIPLE ATTEMPTS THE SEPTUM OF THE PM HAD DISLODGED AND A SCREW WAS NOTED TO BE MISSING. THE PHYSICIAN ELECTED TO EXPLANT THE PM AND IMPLANT A NEW ONE TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268610 ↗
• InjuryJan 21, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED A BACKUP VVI MODE. PROGRAMMING CHANGES WERE ATTEMPTED BUT UNSUCCESSFUL. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127758 ↗
• InjuryDec 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REDNESS AND SWELLING WITH ECCHYMOSIS AT THE DEVICE IMPLANT SITE DUE TO INFECTION. THE PATIENT'S PACEMAKER WAS EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 23894302 ↗
• InjuryNov 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458360 ↗
• InjurySep 2, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED A BACKUP VVI MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935578 ↗
• MalfunctionAug 10, 2025Battery Problem; Unexpected Mode Switch; Battery Problem; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER WENT INTO BACKUP VVI, AND BATTERY IMPEDANCE PROBLEM WAS ALSO OBSERVED. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768173 ↗
• MalfunctionJul 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE SCREW OF THE PACEMAKER CAN¿T BE TIGHTENED AND WAS NOT USED. A NEW PACEMAKER WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS STABLE THROUGHOUT THE IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552577 ↗
• MalfunctionJan 30, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT PATIENT'S PACEMAKER WAS IN BACKUP MODE. NO INTERVENTION WAS DONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274409 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-11035. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH INFECTION, POCKET EROSION AND EXPERIENCING DISCHARGE. THE PHYSICIAN EXPLANTED THE ACTIVE SYSTEM - PACEMAKER AND RIGHT VENTRICULAR LEAD TO RESOLVE THE ISSUE. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 21175648 ↗
• MalfunctionAug 12, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN THE CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS IN BACKUP VVI DUE TO ELECTROMAGNETIC INTERFERENCE. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE AND THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959016 ↗
• MalfunctionAug 3, 2024Failure to Capture; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Failure to Capture; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED WITH PACING INHIBITION AND ELECTROGRAM ANOMALY ON THE PACEMAKER. UPON REVIEW OF TRANSMISSION, IT WAS SUSPECTED THAT THERE WAS TELEMETRY INTERFERENCE THAT HAVE CAUSED THE ISSUE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901154 ↗
• MalfunctionMay 14, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, THE PACEMAKER WAS NOTED TO BE ON BACK-UP MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311853 ↗
• InjuryMar 27, 2024Pacemaker Found in Back-Up Mode; Unexpected Mode Switch; Pacemaker Found in Back-Up Mode; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. DURING THE INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS IN BACK-UP MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987751 ↗
• InjuryMar 25, 2024Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PACEMAKER WAS FOUND IN DEVICE BACK-UP MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966727 ↗
• MalfunctionMar 13, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PACEMAKER WAS UNABLE TO BE INTERROGATE. NO INTERVENTION/PROGRAMMING CHANGES WERE MADE. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892049 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-33927. IT WAS REPORTED THAT THE PATIENT'S PACEMAKER SYSTEM EXHIBITED POCKET EROSION. AN INFECTION WAS NOTED AND CONFIRMED BY CULTURE TESTING. THE WHOLE PACEMAKER SYSTEM WAS EXPLANTED AS A RESULT. PATIENT CONDITION WAS STABLE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 18838733 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT PRESENTED WITH AN INFECTION. THEIR PACEMAKER WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2024. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18743929 ↗
• InjuryFeb 13, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, PREMATURE BATTERY DEPLETION WAS SUSPECTED ON THE DEVICE. 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 18696010 ↗
• MalfunctionFeb 12, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE SET SCREW WAS UNABLE TO BE LOOSENED RESULTING IN THE LEAD BEING UNABLE TO DISCONNECT FROM THE DEVICE. THE LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691757 ↗

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-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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator