Zephyr™ XL DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 944 adverse event reports that list this exact device (DI 05414734501620), received between Jun 12, 2018 and Aug 20, 2026 — classified as 24 deaths, 512 injuries, 408 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (242 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 944 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Loose or Intermittent Connection; Difficult to Remove

  It was reported that during a normal device replacement procedure, the set screw was unable to be removed due to being stripped. The device was left in the patient, and a new system will be implanted at a later date. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348018 ↗
• MalfunctionJul 7, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. FURTHER INFORMATION WAS REQUESTED HOWEVER WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742244 ↗
• InjuryMar 6, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR PREOPERATIONAL CHECKUP. IT WAS NOTED THAT THE PACEMAKER UNABLE TO INTERROGATE. FURTHER INTERROGATION ATTEMPT USING A DIFFERENT PROGRAMMER BUT WAS UNSUCCESSFUL. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528376 ↗
• MalfunctionFeb 27, 2026Difficult to Remove; Failure to Disconnect

  DURING A NORMAL DEVICE EXCHANGE PROCEDURE, MULTIPLE WRENCHES WERE USED TO REMOVE THE LEAD FROM THE DEVICE BUT THE WRENCHES WERE UNABLE TO ENGAGE THE SET-SCREW OF THE DEVICE. THE SILICONE SEAL WAS REMOVED AND THE HEAD OF THE SCREW WAS CLEANED TO TRY AND RESOLVE THE ISSUE, THE WRENCH WAS STILL UNABLE TO ENGAGE THE SET-SCREW AFTER. THE LEAD WAS THEN CUT AND CAPPED TO RESOLVE THE EVENT. THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472309 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH PAIN AT THE IMPLANTED DEVICE POCKET SITE, WITH THE SKIN OVER THE POCKET APPEARING RED, SWOLLEN, WARM TO TOUCH, AND POCKET EROSION. THE PHYSICIAN EXPLANTED THE PACEMAKER DUE TO INFECTION. THE PATIENT REMAINED STABLE THROUGHOUT.

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection

  MAUDE report 23986392 ↗
• InjuryDec 8, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO SYNCOPE, DISCOMFORT, AND DYSPNEA. DEVICE INTERROGATION REVEALED THAT THE PACEMAKER (PM) EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACED THE PM. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Discomfort; Dyspnea; Syncope/Fainting

  MAUDE report 23743682 ↗
• InjuryDec 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PACEMAKER (PM) EXHIBITED PREMATURE BATTERY DEPLETION. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD FAILED TO CAPTURE. THE PHYSICIAN EXPLANTED AND REPLACED THE PM AND RA LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710880 ↗
• MalfunctionNov 24, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT AN ALERT THAT THE DEVICE HAD REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) WAS OBSERVED. 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 23632802 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL DUE TO INFECTION. THE PATIENT HAD SKIN ULCERATION AND THE PHYSICIAN DETERMINED THAT THE INFECTION IS UNRELATED TO ABBOTT PRODUCT OR ABBOTT PROCEDURE DUE TO THE PATIENT LONG HISTORY OF ALCOHOLISM, WHICH IS NOT CONDUCIVE TO WOUND HEALING. THE PACEMAKER WAS EXPLANTED AND THE PATIENT WAS STABLE.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 23592557 ↗
• MalfunctionNov 18, 2025Failure to Interrogate; Use of Device Problem; Unexpected Mode Switch; Failure to Interrogate; Use of Device Problem; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP VISIT, EXPERIENCING CHEST DISCOMFORT AND DIZZINESS. THE PACEMAKER, INITIALLY PROGRAMMED TO ODO MODE, WAS INADVERTENTLY ACTIVATED TO BACKUP VVI MODE BY THE PROGRAMMER. HOWEVER, INTERROGATION OF THE DEVICE WAS UNSUCCESSFUL BECAUSE IT HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). CONSEQUENTLY, SYSTEM RESTORATION COULD NOT BE COMPLETED. THE PATIENT¿S CONDITION WAS UNKNOWN.

  Patient problems: Discomfort; Dizziness

  MAUDE report 23578299 ↗
• MalfunctionNov 11, 2025Failure to Disconnect; Contamination of Device Ingredient or Reagent; Failure to Disconnect; Contamination of Device Ingredient or Reagent

  DURING A ROUTINE DEVICE EXCHANGE, THE VENTRICULAR LEAD WAS NOT ABLE TO BE REMOVED FROM THE HEADER OF THE DEVICE. A WHITE SUBSTANCE WAS VISUALLY OBSERVED ON THE SET SCREW. THE VENTRICULAR LEAD WAS BROKEN AND WAS REMOVED FROM THE HEADER OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526132 ↗
• InjuryOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS IN CRITICAL CONDITION FOR A SUSPECTED UNSPECIFIED DEVICE RELATED PROBLEM. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23368088 ↗
• InjuryOct 22, 2025Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN-CLINIC FOLLOW-UP, ELECTIVE REPLACEMENT INDICATOR (ERI) WAS OBSERVED ON THE DEVICE DUE TO SUSPECTED PREMATURE BATTERY DEPLETION (PBD). TECHNICAL SERVICES REVIEWED THE PATIENT'S RECORDS AND THE PBD WAS NOT CONFIRMED. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358774 ↗
• InjuryOct 15, 2025Failure to Interrogate; Unexpected Mode Switch; Failure to Interrogate; Unexpected Mode Switch

  NEW INFORMATION RECEIVED INDICATES THAT THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306891 ↗
• InjuryOct 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE PACEMAKER POCKET SITE. DURING THE REMOVAL PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD SET SCREW COULD NOT BE DETACHED FROM THE PACEMAKER HEADER. THE PACEMAKER WAS REMOVED, AND THE RV LEAD WAS CUT AND CAPPED ON (B)(6) 2025. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 23302545 ↗
• InjurySep 11, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WENT INTO BACKUP VVI MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023396 ↗
• InjurySep 5, 2025Premature Discharge of Battery; Failure to Interrogate; Insufficient Device Problem Information; Premature Discharge of Battery; Failure to Interrogate; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC AS THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. DURING THE FOLLOW-UP THE PACEMAKER FAILED TO BE INTERROGATED AND FOUND TO BE IN UNIPOLAR MODE. AS A RESOLUTION THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986970 ↗
• MalfunctionSep 2, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A GENERATOR REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE FROZEN IN THE PACEMAKER HEADER AND COULD NOT BE REMOVED. THE HEADER WAS BROKEN TO EXTRACT THE RV LEAD. THE PACEMAKER WAS EXPLANTED AND REPLACED, WHILE THE RV LEAD REMAINED IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935651 ↗
• MalfunctionAug 27, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC DUE TO ARRHYTHMIA AND DISCOMFORT. UPON INTERROGATION, THE PACEMAKER WAS FOUND TO BE IN BACKUP MODE. DEVICE RESTORATION WAS ATTEMPTED, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 22910031 ↗
• InjuryAug 22, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP. UPON DEVICE INTERROGATION, THE PACEMAKER WAS FOUND TO BE IN BACKUP MODE DUE TO BATTERY DEPLETION. 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 22870459 ↗
• InjuryAug 13, 2025Unexpected Mode Switch; Unexpected 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 DUE TO ELECTROMAGNETIC INTERFERENCE. THE PACEMAKER WAS EXPLANTED AND REPLACED.THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792933 ↗
• InjuryAug 1, 2025Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC WITH CHEST TIGHTNESS AND DIZZINESS. LATER IT WAS NOTED THAT THE PACEMAKER FAILED TO BE INTERROGATED DUE TO PREMATURE BATTERY DEPLETION. AS A RESOLUTION THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Discomfort; Dizziness

  MAUDE report 22692772 ↗
• MalfunctionJun 30, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT EXPERIENCES PALPITATIONS. IT WAS NOTED THAT THE DEVICE WAS FOUND IN BACKUP MODE. NO PROGRAMMING CHANGES MADE WERE REPORTED. NO PATIENT STATUS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 22355133 ↗
• MalfunctionJun 25, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PACEMAKER IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER'S SET SCREW STRIPPED. THE PACEMAKER WAS NOT USED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333506 ↗
• InjuryJun 24, 2025Therapy Delivered to Incorrect Body Area; Capturing Problem; Therapy Delivered to Incorrect Body Area; Capturing Problem

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE ATRIAL LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE PATIENT WAS EXPERIENCING DIAPHRAGM STIMULATION, DISCOMFORT AND DIFFICULTY BREATHING. THE LEAD AND PACEMAKER WERE EXPLANTED AND SUCCESSFULLY REPLACED.

  Patient problems: Discomfort; Dyspnea

  MAUDE report 22323477 ↗

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-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-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-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-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