Versa® VEDR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169474277), received between Dec 9, 2016 and Sep 3, 2026 — classified as 1 death, 12 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (8 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 30 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND DIAPHRAGM STIMULATION. REPROGRAMING WAS CONDUCTED AND THEN THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED.  THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 22108377 ↗
• MalfunctionMar 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS CONCERNED REGARDING PACEMAKER DYSFUNCTION. THE PATIENT REPORTED DOING EXERCISE EARLIER AND THOUGHT THEIR DEVICE WASN'T RESPONDING PROPERLY. THE IMPLANTABLE PULSE GENERATOR (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 21584462 ↗
• MalfunctionOct 22, 2024Pacing Problem; Pacing Problem

  IT WAS NOTED THAT THE EMERGENCY MEDICAL SERVICES REPORTED HEART RATE IN THE TWENTIES BUT HAD NO SUPPORTING RHYTHM STRIPS. IT WAS NOTED THAT THE IPG EXHIBITED NORMAL DEVICE FUNCTION.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 20505591 ↗
• MalfunctionFeb 14, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED DUE TO MEDICAL JUDGEMENT AND PATIENT UPGRADED TO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM.

  Patient problems: Bradycardia; Fatigue

  MAUDE report 18702074 ↗
• InjuryJan 19, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE RIGHT V ENTRICULAR (RV) LEAD EXHIBITED HIGH AND RAISING THRESHOLDS. THE RV LEAD WAS CAPPED, THE IPG WAS EXPLANTED AND BOTH DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541782 ↗
• MalfunctionDec 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING THAT THE DEVICE WAS WORKING SINCE A PROCEDURE. THE IMPLANTABLE PULSE GENERATOR (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 18417081 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A FEVER AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Fever

  MAUDE report 17974639 ↗
• MalfunctionSep 1, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED BY THE PROGRAMMER. 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 15334358 ↗
• MalfunctionNov 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 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 12849921 ↗
• MalfunctionSep 15, 2021Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS FURTHER REPORTED THAT INTERVENTION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474150 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. ANTIBIOTIC TREATMENT WAS ADMINISTERED. THE ENTIRE PACING SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11606867 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. MEDICAL INTERVENTION WAS REQUIRED AND THE COMPLETE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11018288 ↗
• InjuryOct 14, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10678196 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10585422 ↗
• MalfunctionMay 7, 2020Capturing Problem; Capturing Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10031817 ↗
• MalfunctionDec 12, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A HIGH PACING RATE WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD ON PRESENTING ELECTROGRAMS (EGM). INTERMITTENT CAPTURE WAS ALSO NOTED. THE RIGHT ATRIAL (RA) LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9456744 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. A REPLACEMENT SYSTEM WAS IMPLANTED ONE WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8964396 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 8939825 ↗
• MalfunctionAug 27, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE POOR TELEMETRY, THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935597 ↗
• MalfunctionJun 13, 2019Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DID NOT EXHIBIT ANY ISSUES AND THE BRADYCARDIA WAS UNRELATED TO THE DEVICE.

  Patient problems: Bradycardia; Dyspnea

  MAUDE report 8696540 ↗
• MalfunctionNov 24, 2018Pacing Problem; Pacing Problem

  IT WAS REPORTED BY A PATIENT'S FAMILY MEMBER THAT THEIR "DEVICE IS SKIPPING BEATS". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100334 ↗
• InjuryJun 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FATIGUE, LETHARGY AND BRADYCARDIA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS FOUND TO HAVE MIGRATED TO A LATERAL/AXILLARY POSITION OVER TIME AND AN X-RAY INDICATED THERE WAS LITTLE OR NO SLACK IN THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED NO CAPTURE, UNDEFINED IMPEDANCE AND WAS SUSPECTED TO HAVE DISLODGED. THE RA LEAD WAS CAPPED AND NOT REPLACED. THE RV LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS MOVED TO THE RIGHT SIDE AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Fatigue; Lethargy

  MAUDE report 7630774 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO AN INFECTION AROUND THE MITRAL VALVE. A LEADLESS PACEMAKER WAS INSERTED AS THE PATIENT WAS PACEMAKER DEPENDENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7455103 ↗

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-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-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-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• 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-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-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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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.