ZephyrRecalls & reported problems across all models

We found 4 models of Zephyr by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,414 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 3, 2026 — classified as 39 deaths, 769 injuries, 606 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (362 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Zephyr problems

Zephyr models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zephyr™ XL DR

  Pulse generator, permanent, implantable
  24 deaths944 reports
• Zephyr® DR

  Pulse generator, permanent, implantable
  9 deaths219 reports
• Zephyr™ XL SR

  Pulse generator, permanent, implantable
  2 deaths161 reports
• Zephyr® SR

  Pulse generator, permanent, implantable
  4 deaths90 reports

Recent Zephyr adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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