Versa™ VEDR01 (UDI 00613994222114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 328 adverse event reports that list this exact device (DI 00613994222114), received between Feb 9, 2017 and Sep 29, 2026 — classified as 10 deaths, 184 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (48 reports).

16 other recalls cover devices cleared under the same FDA submission (P980035); 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 328 reports, 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 ↗
• 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 ↗
• 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 10, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED TELEMETRY ISSUE. IT WAS NOTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE IPG WAS EXPLANTED AND REPLACED UPON REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469936 ↗
• InjuryJun 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22271989 ↗
• MalfunctionApr 1, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AN UNKNOWN ELECTRICAL RESET AND HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738334 ↗
• InjuryFeb 21, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WITH A HEART RATE IN THE RANGE OF FORTY BEATS PER MINUTE WHICH IS BELOW THE LOWER RATE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21431821 ↗
• InjuryFeb 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH OUTPUT. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396123 ↗
• MalfunctionFeb 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS ALSO REPORTED THAT THE HEALTHCARE PROFESSIONAL WAS UNABLE TO INTERROGATE THE PATIENTS PACEMAKER WITH THE CARE LINK MONITOR. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 21392950 ↗
• MalfunctionJan 21, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW PROGRAMMED SETTINGS. THE IPG WAS EXPLANTED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21195669 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077671 ↗
• InjuryDec 6, 2024Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS FURTHER REPORTED THAT THE IPG COULD BE REACHING ELECTIVE REPLACEMENT INDICATOR (ERI)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862809 ↗
• InjuryNov 27, 2024Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797009 ↗
• MalfunctionNov 18, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD NO TELEMETRY AND COULD NOT BE INTERROGATED. THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704884 ↗
• InjuryNov 6, 2024Output above Specifications; Battery Problem; Output above Specifications; Battery Problem

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620990 ↗
• MalfunctionSep 19, 2024Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI.

  Patient problems: Dizziness

  MAUDE report 20254906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980035. One submission often covers many models, so check the product and lot details in each record.

• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-0810-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
• Z-0809-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
• Z-0808-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
• Z-0806-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Mo
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• Z-0807-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number
• Z-2120-2011 · Apr 4, 2011 · Terminated
  Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Wit
• Z-1440-2010 · Feb 11, 2010 · Terminated
  Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects,

…and 1 more.