Adapta™ ADDR01 (UDI 00613994222046)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,801 adverse event reports that list this exact device (DI 00613994222046), received between Dec 10, 2014 and Sep 28, 2026 — classified as 39 deaths, 1,045 injuries, 717 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (295 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 1,801 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient experienced a syncopal episode. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50912134 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The organism was identified as Enterococcus faecalis. It was further noted that the patient experienced bacteremia and discomfort.  The patient was administered antibiotics. The IPG system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Discomfort; Unspecified Infection

  MAUDE report 50882046 ↗
• InjurySep 9, 2026Premature Discharge of Battery; Pacing Problem

  It was reported that the patient experienced bradycardia, pre-syncope and shortness of breath. It was further reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion and a pacing problem. It was further noted that the Right Ventricular (RV) lead exhibited high impedance, polarity switch and loss of capture. The IPG was explanted and the RV lead was capped. No patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dyspnea; Presyncope

  MAUDE report 50688440 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647327 ↗
• MalfunctionAug 18, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296471 ↗
• InjuryJul 30, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient was found unresponsive on the floor. The patient's wife stated she was told the pacemaker just died, it just stopped working.  The Implantable Pulse Generator (IPG) was explanted and replaced due to normal Elective Replacement Indicator (ERI). No further patient complications have been reported as a result of this event.

  Patient problems: Loss of consciousness

  MAUDE report 50081788 ↗
• MalfunctionJun 10, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED. TROUBLESHOOTING STEPS WERE INSUFFICIENT TO RESOLVE THE ISSUE. 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 25454854 ↗
• MalfunctionMay 22, 2026Reset Problem

  IT WAS REPORTED THAT THERE WAS AN ELECTRICAL RESET, SINGLE CHAMBER FIXED RATE (VVI) SIXTY FIVE (65) BEATS PER MINUTE (BPM). THE DEVICE WAS EXPLANTED AND REPLACED DUE NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)- RECOMMENDED REPLACEMENT TIME (RRT) WAS TRIGGERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253902 ↗
• MalfunctionMay 18, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A HEART RATE IN THE THIRTIES AND FORTIES. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25199383 ↗
• MalfunctionMay 12, 2026Failure to Interrogate

  IT WAS REPORTED THAT THEY WERE UNABLE TO INTERROGATE THE DEVICE. 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 25149470 ↗
• MalfunctionMay 5, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE MONITOR WAS UNABLE TO CATCH TELEMETRY FROM THE DEVICE DESPITE TROUBLESHOOTING, AND A ¿READER POSITION NO TELEMETRY¿ ISSUE WAS NOTED. NO TELEMETRY WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT 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 25078970 ↗
• MalfunctionApr 21, 2026Pacing Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAUSES. IT WAS FURTHER NOTED THAT THE RV LEAD EXHIBITED LOW IMPEDANCE AND A POLARITY SWITCH. IT WAS ALSO NOTED THAT THE IPG EXHIBITED A ELECTRICAL RESET.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes

  MAUDE report 24940127 ↗
• InjuryApr 14, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) CAPTURE MANAGEMENT UNEXPECTEDLY WENT TO HIGH PACING OUTPUTS WHICH DEPLETED THE BATTERY EXCESSIVELY. 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 24869325 ↗
• InjuryApr 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED "A VIBRATION IN MY CHEST" AND THAT THE BATTERY WAS FAILING IN THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS EXPLANTED AS WAS REPLACED. N OFURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24854978 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION WITH VEGETATION NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED A CONFIRMED FRACTURE, AN UNDEFINED OUT OF RANGE SPIKE IN IMPEDANCE, AND NO CAPTURE. 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

  MAUDE report 24831016 ↗
• MalfunctionApr 7, 2026Migration or Expulsion of Device

  THE PATIENT REPORTED THAT WITH THEIR FIRST PACEMAKER (PM), SHORTLY AFTER IMPLANT THEY WENT THROUGH A COURTHOUSE SCANNER AND AFTERWARDS THEY BEGAN TO FEEL UNWELL. THE PATIENT WAS TAKEN TO A NEARBY FIRE STATION WHERE THEY WERE RESUSCITATED AND THEN BROUGHT TO HOSPITAL. ONCE AT THE HOSPITAL PATIENT SAID THEIR DEVICE WAS CHECKED AND THEY WERE TOLD "SOMETHING TURNED OFF" THE PM. THE DEVICE WAS REPROGRAMMED IT AND IT THEN WORKED AS INTENDED. THE PATIENT REPORTED THAT THEIR CURRENT DEVICE HAS DROPPED DOWN A BIT FROM IT'S PLACEMENT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800242 ↗
• InjuryMar 31, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT STATED THEIR OLD IMPLANTABLE PULSE GENERATOR (IPG) WAS "DEFECTIVE." 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 24740261 ↗
• InjuryMar 26, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS "BAD". THE IPG 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 24699314 ↗
• MalfunctionMar 25, 2026Battery Problem

  IT WAS REPORTED THAT  BY THE PATIENT THAT THEY "NEED AN MRI BUT NO ONE WILL DO IT. I NEED TO GET THIS PACEMAKER TAKEN OUT , THE BATTERY IS DEAD" 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 24685368 ↗
• InjuryMar 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING. THE IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions; Palpitations

  MAUDE report 24518975 ↗
• MalfunctionMar 4, 2026Failure to Interrogate

  IT WAS REPORTED THAT THEY CANNOT INTERROGATE THE DEVICE USING THE REMOTE MONITORING MOBILE APPLICATION. TECHNICAL SUPPORT CONFIRMED USING THE CORRECT APPLICATION. CALLER STATED THEY HAD PUT THE READER OVER THE DEVICE AND NO DEVICE SERIAL NUMBER. THEY HAD STATED THE GREEN BAR STARTED GOING ACROSS AND STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506165 ↗
• InjuryMar 3, 2026Battery Problem; Reset Problem

  IT WAS REPORTED THAT A FULL ELECTRICAL RESET OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOUR DAYS LATER DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) - RECOMMENDED REPLACEMENT TIME (RRT) WAS TRIGGERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Fatigue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493460 ↗
• MalfunctionFeb 26, 2026Pacing Problem

  IT WAS REPORTED THAT THE REMOTE MONITORING MOBILE DISPLAYED NO DEVICE FOUND MESSAGE WHEN ATTEMPTED TO INTERROGATE THE PATIENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454678 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE EVENT WAS NOT RELATED TO THE IPG SYSTEM.

  Patient problems: Cardiac Arrest

  MAUDE report 24330421 ↗
• InjuryFeb 6, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS RESULTING IN PREMATURE DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG). IT CAN BE NOTED THAT THE DEVICE WAS DETECTING FALSE THRESHOLDS RESULTING IN CAPTURE MANAGEMENT INCREASING OUTPUTS. 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 24277927 ↗

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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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-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.