Adapta™ L ADDRL1 (UDI 00613994222084)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,072 adverse event reports that list this exact device (DI 00613994222084), received between Oct 1, 2015 and Sep 18, 2026 — classified as 20 deaths, 582 injuries, 470 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (204 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 1,072 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Pacing Problem

  Patient problems: Discomfort

  MAUDE report 50825835 ↗
• InjurySep 3, 2026Pacing Problem

  It was reported that the patient experienced chest pain. It was noted that the Implantable Pulse Generator (IPG) had reached Elective Replacement Indicator (ERI). It was also reported that the patient experienced a heart rate below the programmed lower rate limit of the IPG. The patient was admitted to hospital. The IPG remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Chest Pain

  MAUDE report 50588276 ↗
• InjurySep 1, 2026Electromagnetic Interference; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540678 ↗
• MalfunctionAug 28, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507777 ↗
• MalfunctionAug 12, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219227 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced infection. 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: Unspecified Infection

  MAUDE report 50214853 ↗
• MalfunctionAug 6, 2026Reset Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157217 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Syncope/Fainting

  MAUDE report 50050942 ↗
• MalfunctionJun 30, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE CONCERNED ABOUT THEIR IMPLANTABLE PULSE GENERATOR (IPG) LONGEVITY. 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 25665898 ↗
• MalfunctionJun 30, 2026Output Problem

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD SLIGHTLY ELEVATED OUTPUTS, RESULTING IN DECREASE IN BATTERY ESTIMATE SINCE THE LAST CARELINK TRANSMISSION. 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 25665756 ↗
• MalfunctionJun 11, 2026Failure 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 25469497 ↗
• MalfunctionJun 4, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CAPTURE MANAGEMENT HAS BEEN OBSERVED TO INTERMITTENTLY SWITCH TO HIGH PACING OUTPUTS, WHICH CAN LEAD TO EXCESSIVE BATTERY DEPLETION. 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 25393080 ↗
• MalfunctionMay 29, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THEY WERE UNABLE TO INTERROGATE DEVICE WITH CARELINK EXPRESS APP. REBOOTED APP AND TABLET BUT STILL COULD NOT SEE DEVICE. THERE ARE PACED BEATS ON THE MONITOR. 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 25329282 ↗
• MalfunctionMay 28, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIGHTHEADEDNESS/DIZZINESS AND BRADYCARDIA IN THE FORTIES WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH POSSIBLE PACING BELOW THE LOWER RATE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD WARNING FOR HIGH UNDEFINED IMPEDANCE. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 25317880 ↗
• MalfunctionMay 26, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE WHEN INTERROGATING A PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WHICH EXHIBITED A TELEMETRY ISSUE. THE PROGRAMMER 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 25275985 ↗
• InjuryMay 18, 2026Pacing Problem

  ON (B)(6) 2026: IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN AN ARRYTHMIA AND WAS CARDIOVERTED.

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

  MAUDE report 25198579 ↗
• InjuryMay 15, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) "STOPPED WORKING". 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 25183176 ↗
• MalfunctionMay 11, 2026Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AN UNKNOWN ELECTRICAL RESET WHEN IT WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). 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 25144810 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 24995274 ↗
• InjuryApr 10, 2026Reset Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND THAT THE DEVICE WAS NOT WORKING. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AN ELECTRICAL RESET DUE TO END OF SERVICE (EOS) STATUS. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND A POSSIBLE LOSS OF CAPTURE. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. THE RA LEAD AND THE RV LEAD REMAIN IN USE. IT WAS FURTHER REPORTED THAT REMOTE MONITORING NETWORK REPORT HAD INVALID DATA. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 24843917 ↗
• InjuryApr 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE 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 24830130 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POCKET INFECTION AND VEGETATION ON THE LEADS. THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24829915 ↗
• MalfunctionApr 8, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD ELECTROMAGNETIC INTERFERENCE TRIGGERING EPISODE MISCLASSIFICATION. 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 24815000 ↗
• MalfunctionApr 7, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT STATED "FEELING LIKE SHE IS GOING TO PASS OUT", "NOT GETTING ANY OXYGEN" AND THE PACEMAKER STATED, "IT'S REAL LOOSE" AND "FLOPPING AROUND". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS UN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 24800489 ↗
• InjuryMar 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE IPG REMAINS IN USE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PREVIOUS NON PHYSIOLOGIC OVERSENSING. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24690062 ↗

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-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-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-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-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-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.