VersaRecalls & reported problems across all models

We found 4 models of Versa by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 578 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 29, 2026 — classified as 52 deaths, 287 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (138 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Versa recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 17, 2019Open, Classified

   A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

   Z-0811-2019 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗

Most reported Versa problems

Versa models

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

• Versa™ VEDR01

  Implantable pulse generator, pacemaker (non-CRT)
  10 deaths328 reports
• Versa™ VEDR01

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall19 deaths122 reports
• Versa™ VEDR01

  Pulse generator, permanent, implantable
  1 recall22 deaths98 reports
• Versa® VEDR01

  Implantable pulse generator, pacemaker (non-CRT)
  1 death30 reports

Recent Versa adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Syncope/Fainting

  MAUDE report 50933167 ↗
• MalfunctionSep 14, 2026Failure to Interrogate

  It was reported that the Implantable Pulse Generator (IPG) could not be interrogated. The device remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751040 ↗
• MalfunctionSep 3, 2026Pacing Problem

  It was reported that patient experienced an abnormal heart rate. Upon device assessment pacing spikes were noted. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50588259 ↗
• MalfunctionMay 12, 2026Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT WITH A IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED NO TELEMETRY WITH THE MYCARELINK MONITOR WHILE TRYING TO SEND A TRANSMISSION, AND THE TRANSMISSION PROGRESS INDICATOR BECAME STUCK AT 25% WITHOUT ADVANCING. THE ISSUE WAS DESCRIBED AS A READER POSITION PROBLEM. TROUBLESHOOTING WAS PERFORMED BY POWER CYCLING THE MONITOR, MOVING THE READER, AND USING A DRY WASHCLOTH, BUT THE ISSUE WAS NOT RESOLVED. THE IPG REMAINS IN USE. THE PATIENT WAS REFERRED TO THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147499 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND SEPSIS. THE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25109157 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION AND VEGETATION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Medical device site infection

  MAUDE report 24774699 ↗
• MalfunctionMar 31, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TELEMETRY. IT WAS FURTHER NOTED THAT A READER POSITION ISSUE OCCURRED WITH THE REMOTE MONITOR SYSTEM DURING AN ATTEMPT TO TRANSMIT DATA FROM A PACEMAKER. THE PATIENT WAS UNABLE TO ESTABLISH TELEMETRY, AND THE GREEN PROGRESS BAR FAILED TO REACH 100% DURING THE TRANSMISSION ATTEMPT. THE TRANSMISSION WAS NOT COMPLETED, AND NO CODE WAS DISPLAYED. THE MONITOR WAS ALWAYS PLUGGED IN, AND TROUBLESHOOTING STEPS INCLUDED RESTARTING THE READER, ADJUSTING THE READER POSITION, RESTARTING THE MONITOR, AND PLACING A DRY WASHCLOTH. WHEN ATTEMPTING TO END THE TRANSMISSION WITH THE DRY WASHCLOTH, THE PATIENT ACCIDENTALLY HUNG UP AND WAS UNABLE TO RECONNECT. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741603 ↗
• MalfunctionOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO OBVIOUS SPIKES. THE HEALTH CARE PROFESSIONAL SUSPECTED WHETHER THE IPG IS WORKING APPROPRIATELY. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300490 ↗
• MalfunctionSep 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND REMOTE MONITOR EXHIBITED ISSUES DURING AN ATTEMPTED MANUAL TRANSMISSION OF DEVICE DATA, INCLUDING THE TELEMETRY BAR NOT COMPLETING (LESS THAN HALF COMPLETED) AND A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH MYCARELINK. THE CLINICIAN ATTEMPTED THE WASHCLOTH TECHNIQUE TO IMPROVE TELEMETRY, BUT THE ISSUE PERSISTED. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081644 ↗
• MalfunctionAug 19, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BRADYCARDIA WITH A HEART RATE IN THE THIRTIES OBSERVED. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS SUSPECTED TO BE FAILING. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22839833 ↗
• MalfunctionAug 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT THOUGHT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794588 ↗
• InjuryAug 13, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MAY HAVE EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED THRESHOLDS. THE IPG WAS REMOVED AND REPLACED AND THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792150 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAINS AND A COMPLETE HEART BLOCK. THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. THE IPG WAS EXPLANTED AND REPLACED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Heart Block; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769523 ↗
• InjuryAug 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THAT WERE EXPERIENCING SHORTNESS OF BREATH, CHEST PAIN, EDEMA AND CAN BARELY WALK FROM ONE SIDE OF THE ROOM TO THE OTHER. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI), THEREFORE IT WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT EXPERIENCED FLUID BUILD-UP IN THEIR HEART. THE PATIENT WAS ADMITTED TO HOSPITAL FOR WEEKS IN ORDER TO GET SWELLING UNDER CONTROL. THE PATIENT'S REP ALSO STATED THAT "A FEW WEEKS AFTER PATIENT WAS HOME, AND STILL NEEDING CARE FOR SWELLING, SHE HAD HER DEVICE CHANGED OUT AND ALL OF HER SWELLING WENT AWAY". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dyspnea; Swelling/ Edema

  MAUDE report 22684626 ↗
• MalfunctionJul 21, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THERE WAS NO TELEMETRY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE MONITOR, A READER POSITION ISSUE, AND THE PROGRESS BAR DID NOT MOVE. THE READER WAS ADJUSTED, THE MONITOR WAS POWER CYCLED, A WASHCLOTH WAS USED, AND ELECTROMAGNETICINTERFERENCE WAS CHECKED FOR BUT NOT FOUND. THE ISSUE WAS REFERRED TO A CLINIC. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554128 ↗

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