Versa™ VEDR01 (UDI 00643169709072)Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00643169709072), received between Apr 10, 2018 and May 7, 2026 — classified as 22 deaths, 37 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (35 reports).

1 FDA recall record name this device's identifier, 1 still open.

15 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.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507412 ↗
• InjurySep 13, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210002 ↗
• InjuryJun 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575817 ↗
• DeathMay 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350618 ↗
• DeathMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, A CAUSE OF DEATH COULD NOT BE IDENTIFIED. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19339342 ↗
• MalfunctionMar 28, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WITH A HEART RATE IN THE THIRTIES IN BEATS PER MINUTE (BPM) NOTED. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER PROGRAMMED RATE OF SEVENTY BPM. THE RV LEAD AND IPG REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18994785 ↗
• MalfunctionMar 19, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO COMPLETE TELEMETRY WITH THE IMPLANTABLE PULSE GENERATOR (IPG). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED PATIENT TO THE CLINIC. THE REMOTE MONITOR REMAINS IN USE. 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 18933548 ↗
• MalfunctionNov 14, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT THE IPG BATTERY STATUS AND DEVICE HISTORY WERE ALL IN NORMAL RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130364 ↗
• InjuryApr 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS NOT EXPLANTED DUE TO THE DEVICE CIRCUIT ERROR AND THAT IT WAS EXPLANTED TO FACILITATE A PACING SYSTEM UPGRADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742077 ↗
• DeathMar 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 16573645 ↗
• DeathDec 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 16021641 ↗
• InjuryAug 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR AN UNKNOWN REASON. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281685 ↗
• InjuryFeb 28, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG)  DUE TO CHRONIC  HIGH CAPTURE THRESHOLDS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE IPG WAS EXPLANTED AND REPLACED WHILE 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 13619760 ↗
• DeathFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 13604575 ↗
• InjuryDec 29, 2021Pacing Problem; Pacing Problem

  FOLLOW UP REVEALED THE PATIENT WAS BROUGHT IN TO THE CLINIC AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112854 ↗
• DeathDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 12973017 ↗
• InjuryJul 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS NOT REPLACED IN RESPONSE TO THE ADVISORY BUT WAS A PROPHYLACTIC UPGRADE TO A BI-VENTRICULAR (BI-V) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251447 ↗
• MalfunctionJun 24, 2021Pacing Problem; Pacing Problem

  IT WAS LATER REPORTED THAT DURING AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE, AN ADDITIONAL VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12056912 ↗
• DeathApr 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751334 ↗
• InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THERE WAS NO KNOWN MALFUNCTION/PERFORMANCE ISSUE WITH THE IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730524 ↗
• MalfunctionApr 1, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM. FOLLOW-UP WAS ATTEMPTED; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THIS INCIDENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605908 ↗
• DeathMar 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 11579256 ↗
• DeathMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 11509447 ↗
• MalfunctionJan 11, 2021Pacing Problem; Pacing Problem

  IT WAS LATER REPORTED THAT DURING AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE, AN ADDITIONAL VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11151710 ↗

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-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• 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-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-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-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-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-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,
• Z-1515-2009 · May 18, 2009 · Terminated
  Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive Pacemaker, models KDR601, KDR603, KDR606, KDR651, KDR653, KDR701, KDR703, KDR706