Adapta® L ADDRL1Recalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 00643169474178), received between Dec 6, 2016 and Sep 8, 2026 — classified as 4 deaths, 89 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (34 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 175 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient's representative that the patient is "reacting badly" to the Implantable Pulse Generator (IPG) system with plans for a system revision. The IPG system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50671249 ↗
• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that by the patient's representative that during Implantable Pulse Generator (IPG) implant something was "nicked." The IPG was implanted and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50671214 ↗
• InjuryAug 25, 2026Premature Discharge of Battery

  It was reported that the epicardial Right Ventricular (RV) lead exhibited rising and high thresholds resulting in the ventricular pacing output increasing to 5.0 Volts at 1.0 milliseconds, increasing pacing output, resulting in increased battery utilization and contributed to the Implantable Pulse Generator (IPG) reaching Recommended Replacement Time (RRT) sooner than previously estimated. The IPG was explanted. The RV lead was capped and remains in the patient. A leadless IPG was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430959 ↗
• MalfunctionApr 16, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRANSIENT ELEVATED EXIT BLOCK AND PAUSES. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. IT WAS FURTHER NOTED THAT THE RV LEAD EXHIBITED RISING, VARIABLE AND HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING AND VARIABLE SENSING. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PROGRAMMED SETTINGS ON THE RV LEAD WERE RESULTING IN A HIGHER CURRENT DRAIN ON THE IPG. THE IPG 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 24894411 ↗
• MalfunctionJan 7, 2026Failure to Interrogate

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE REMOTE MONITOR AND THE IMPLANTABLE PULSE GENERATOR (IPG) HAD NO TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO CLINIC. THE MONITOR AND 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 23988845 ↗
• DeathDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS AND BREATH AND PASSED AWAY. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED.

  Patient problems: Cardiac Arrest; Chest Pain; Dyspnea; Vomiting

  MAUDE report 23875330 ↗
• MalfunctionSep 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD CONCERNS ABOUT THE DEVICE FUNCION. 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 23083105 ↗
• MalfunctionAug 28, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY, THE PROGRESS BAR STOPPING AND BEEPING, AND THE READER LIGHTS BLINKING TWICE. THE PATIENT ATTEMPTED TO SEND A TRANSMISSION, AND TROUBLESHOOTING STEPS INCLUDED CONFIRMING THE MONITOR WAS ALWAYS PLUGGED IN, RESTARTING BOTH THE READER AND THE MONITOR, OBSERVING A FLASHING BLUE LIGHT, ATTEMPTING TO REPOSITION THE READER, AND PLACING A DRY WASHCLOTH, BUT NONE OF THESE ACTIONS RESOLVED THE ISSUE. THE PATIENT WAS REFERRED TO A CLINIC TO CHECK THE IMPLANT BATTERY AND TO CHECK THE DEVICE WITH A PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911977 ↗
• MalfunctionJun 6, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO BE INTERROGATED WITH THE MOBILE PROGRAMMER. THE IPG AND THE MOBILE PROGRAMMER 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 22156682 ↗
• InjuryJun 5, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT SINCE SHORTLY AFTER IMPLANT, THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED DIMINISHED SENSING. THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO EXHIBITED POSSIBLE FALSE ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG SYSTEM WAS REPROGRAMMED AND THEN EXPLANTED AND REPLACED. THE RV LEAD PARTIALLY BROKE OFF DURING TIGHT-RAIL EXTRACTION AND THE REMAINDER WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148676 ↗
• InjuryMay 12, 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. THE 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 22000549 ↗
• MalfunctionMay 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAS NOT BEEN FEELING WELL EVER SINCE THE IMPLANTABLE PULSE GENERATOR (IPG) SETTINGS WERE REPROGRAMMED. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) CLINICAL DATA REVIEW FILE WAS ANALYZED AND RESULTS WERE OUT OF SPECIFICATION.

  Patient problems: Insufficient Information

  MAUDE report 21983632 ↗
• MalfunctionMar 14, 2025Pacing Problem; Communication or Transmission Problem; Pacing Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS POSSIBLY PACING BELOW THE LOW ER RATE. IT WAS ALSO REPORTED THAT THE HEALTHCARE PROVIDER WAS UNABLE TO INTERROGATE THE DEVICE. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21604002 ↗
• InjuryFeb 13, 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), RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED FOUR WEEKS POST IMPLANT DUE TO AN INFECTION. THE PATIENT WAS LATER IMPLANTED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21374449 ↗
• MalfunctionFeb 5, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS NOT ESTABLISHING TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC NO SUCCESSFUL TELEMETRY TRANSMISSION COULD BE OBTAINED ON THE DEVICE ON TELEMETRY. THE MONITOR AND THE IMPLANTABLE PULSE GENERATOR (IPG) 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 21310593 ↗
• MalfunctionJan 17, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTABLE PULSE GENERATOR (IPG). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED THE PATIENT TO THE CLINIC, MAKE THE APPOINTMENT WITH THE MONITOR TO DO THE PROCESS AND ALSO TO CHECK THE DEVICE SETTINGS AT THE OFFICE. THE MONITOR AND THE IPG 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 21178501 ↗
• InjuryDec 2, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED ASYSTOLE AFTER THE CARDIOVERSION RECEIVED DUE TO THEIR ATRIAL FIBRILLATION (AF). WHEN CHECK ED THE IMPLANTABLE PULSE GENERATOR (IPG) FAILED TO PACE RESULTING IN THE ASYSTOLE AFTER THE CARDIOVERSION PROCEDURE SINCE THE PADS WERE PLACED OVER THE IPG DURING THE CARDIOVERSION PROCESS. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817563 ↗
• InjuryNov 1, 2024Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: Syncope/Fainting

  MAUDE report 20585663 ↗
• InjuryOct 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428991 ↗
• MalfunctionOct 7, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LONGEVITY OF THE IMPLANTABLE PULSE GENERATOR (IPG) DECREASED DRASTICALLY DUE TO INCREASE IN PACING RATE DURING PREGNANCY. 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 20381538 ↗
• MalfunctionSep 17, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WILL DO AN APPOINTMENT WITH THE DOCTOR. THE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT ABLE TO ESTABLISH TELEMETRY. 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 20235134 ↗
• InjurySep 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR PACEMAKER "TWEAKED." AFTER HAVING THEIR PACEMAKER TWEAKED THEY EXPERIENCED BURNING IN THEIR CHEST. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 20169637 ↗
• MalfunctionAug 7, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED BRADYCARDIA. IT WAS FURTHER REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE. THE IPG SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19926527 ↗
• InjuryJul 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS WHILE THE DEVICE LATCHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY WAS DECREMENTING SO FAST. THE LEAD REMAINS IN USE. 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 19825749 ↗
• InjuryJul 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW HEARTS AND THE IMPLANTABLE PULSE GENERATOR (IPG) MALFUNCTIONED. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19748346 ↗

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