Adapta® ADDR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 00643169441873), received between Dec 6, 2016 and Sep 25, 2026 — classified as 7 deaths, 121 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (39 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 229 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50895752 ↗
• MalfunctionSep 16, 2026Device-Device Incompatibility

  It was reported by the patient that they experienced high blood pressure and not feeling well after an Magnetic Resonance Imaging (MRI) scan. It was also noted that the Implantable Pulse Generator (IPG) is not labelled for MRI. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 50785884 ↗
• InjurySep 11, 2026Premature Discharge of Battery

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. It was also reported that the Right Atrial (RA) lead displayed low impedance and Right Ventricular (RV) lead exhibited rising thresholds. The IPG was explanted and replaced. Both the leads 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 50733940 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Pulse Generator (IPG) system was explanted due to an infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50451166 ↗
• MalfunctionAug 7, 2026Pacing Problem

  Patient problems: Bradycardia; Dizziness

  MAUDE report 50174349 ↗
• MalfunctionJul 7, 2026Under-Sensing

  IT WAS REPORTED THAT THE DEVICE APPEARS TO UNDERSENSE ONE ATRIAL BEAT ON THE CURRENT ELECTROGRAMS (EGM). 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 25733403 ↗
• MalfunctionMay 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ABNORMAL FUNCTION. 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 25091911 ↗
• MalfunctionApr 28, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE PROGRESS BAR NEVER APPEARING DURING ATTEMPTED TRANSMISSION. TROUBLESHOOTING INCLUDED ADJUSTING THE READER POSITION, POWER CYCLING THE MONITOR, USING A TOWEL, AND REMOVING INTERFERENCES. THE PATIENT WAS REFERRED TO A CLINIC TO HAVE THE IMPLANT CHECKED FOR A SUSPECTED IMPLANT/CONNECTION ISSUE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM 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 25013644 ↗
• InjuryApr 10, 2026Premature Discharge of Battery; Pacing Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS EXTREMELY LONG AN ATRIOVENTRICULAR DELAY THAT WAS CAUSING SOME 'PACEMAKER CHALLENGES' WHICH, TOGETHER WITH HIGH RV LEAD PACING OUTPUTS, NECESSITATED REPROGRAMMING. 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 24845057 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT GOT MERSA AFTER THEIR SECOND PACEMAKER WAS IMPLANTED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 24813535 ↗
• MalfunctionFeb 10, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE OF THE MYCARELINK READER WITH A PACEMAKER, THERE WAS A READER POSITION PROBLEM AND NO TELEMETRY WAS ESTABLISHED. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE POSITION OF THE READER; HOWEVER, THE ISSUE WAS NOT RESOLVED, AND THE PATIENT WAS REFERRED TO THE CLINIC. 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 24301939 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL WITH MALAISE AND IMPLANTABLE PULSE GENERATOR (IPG) SITE SWELLING, FEVER, CONFUSION, HYPERTENSION AND FLUID IN THE IPG POCKET INFECTION. THE PATIENT FURTHER EXPERIENCED SEPSIS DUE TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS ENDOCARDITIS. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) AND MEDICATION WAS ADMINISTERED. THE IPG SYSTEM WAS EXPLANTED AND FLUID WAS DRAINED. THE PATIENT WAS TRANSIENTLY HYPOTENSIVE AND A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED MITRAL VALVE VEGETATION. THE PATIENT ALSO HAD TRACE LEFT LOWER EXTREMITY EDEMA. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24019604 ↗
• InjuryDec 30, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE UNEXPECTED BATTERY DEPLETION. 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 23920401 ↗
• MalfunctionDec 18, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO BE INTERROGATED. 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 23839314 ↗
• DeathSep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SPIKE AND HIGH IMPEDANCE. THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT).

  Patient problems: Insufficient Information

  MAUDE report 23050259 ↗
• MalfunctionAug 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED INTERRUPTED TELEMETRY OBSERVED ON ELECTROGRAMS (EGM). 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 22901895 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PRE-SYNCOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope

  MAUDE report 22563126 ↗
• MalfunctionJul 14, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TELEMETRY. THE IPG REMAINS IN USE. THERE WAS A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH THE MYCARELINK MONITOR FOR A PACEMAKER. THE PATIENT REPRESENTATIVE CALLED REGARDING THE ISSUE. TROUBLESHOOTING STEPS PER PRODUCT LABELING DONE AND ADDITIONAL GUIDANCE FOR READER POSITION WITH NO TELEMETRY. THE PATIENT TURNED OFF ELECTRONIC DEVICES AS PART OF THE RESOLUTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500616 ↗
• DeathJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Medical device site infection; Unspecified Infection

  MAUDE report 22477655 ↗
• MalfunctionJun 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE DEVICE WAS EXPLANTED AND REPLACED TO 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 22334608 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion

  MAUDE report 22132608 ↗
• MalfunctionApr 29, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, UNKNOWN SYMPTOMS, AND PREMATURE VENTRICULAR CONTRACTIONS (PVC). THE PATIENT STATED THAT IMPLANTABLE PULSE GENERATOR (IPG) HAD AN ISSUE AND THEIR HEART RATE WAS BELOW THE LOWER RATE OF THE IPG. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 21924318 ↗
• InjuryMar 27, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) HAD "MISFIRED". THE PATIENT EXPERIENCED A FEELING THAT THEIR CHEST "WAS BEING STEPPED ON". THE PATIENT ENDED UP BEING HOSPITALIZED. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 21707621 ↗
• InjuryMar 26, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED. RV THRESHOLD WAS NORMAL AT THE TIME OF THE PROCEDURE. THE RA THRESHOLD WAS UNABLE TO BE TESTED DUE TO ATRIAL ARRHYTHMIA. THE PHYSICIAN ALLEGED NO CONCERN OR ISSUE REGARDING THE DEVICE OR LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696933 ↗
• MalfunctionFeb 21, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED RECOMMENDED REPLACEMENT TIME (RRT) EARLY. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUTPUTS/HIGH THRESHOLDS. THE IPG AND RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432065 ↗

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-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-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-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-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-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-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-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.