Adapta™ ADDR03 (UDI 00613994222060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00613994222060), received between Feb 9, 2017 and Feb 3, 2026 — classified as 1 death, 15 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION OF UNKNOWN ORIGIN. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED A FEVER. 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: Fever; Unspecified Infection

  MAUDE report 24247104 ↗
• MalfunctionSep 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED. 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 23014362 ↗
• InjuryJan 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED DUE TO UNSPECIFIED MALFUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066002 ↗
• InjurySep 29, 2023Migration or Expulsion of Device; Misconnection; Migration or Expulsion of Device; Misconnection

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MIGRATED. IT WAS ALSO REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE STUCK IN THE HEADER. THE IMPLANTABLE PULSE GENERATOR (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 17841899 ↗
• InjuryApr 19, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOTED TO BE PACING BELOW THE LOWER RATE. THE IPG WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16768895 ↗
• InjuryJan 20, 2023Adverse 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 16214647 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FUR THER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2022 IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY EXPERIENCED A WEEPING SWOLLEN WOUND POST EXPLANT AND HOSPITALIZATION FOR 9 DAYS WITH ANTIBIOTICS PRIOR TO IMPLANT OF REPLACEMENT IPG.

  Patient problems: Unspecified Infection

  MAUDE report 16012497 ↗
• MalfunctionDec 19, 2022High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE OUTLIER LEAD IMPEDANCE MEASUREMENT FOR THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. 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 16003818 ↗
• MalfunctionAug 19, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO 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 15256763 ↗
• MalfunctionJul 19, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RACING HEART/FLUTTER. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNDERREPORTING ATRIAL FIBRILLATION EPISODES DUE TO POST MODE SWITCH OVERDRIVE PACING (PMOP) BEING PROGRAMMED ON AND COLLECTION DELAY BEING SET TO A NON-ZERO. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 15050513 ↗
• InjuryApr 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR DEVICE " WAS NO LONGER WORKING" . THE IMPLANTABLE PULSE GENERATOR (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 14069167 ↗
• InjuryDec 14, 2021Premature Discharge of Battery; Premature 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 12998510 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12954389 ↗
• InjuryNov 25, 2020Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT NO MALFUNCTION WAS NOTED ON THE IPG.

  Patient problems: Syncope/Fainting

  MAUDE report 10905660 ↗
• MalfunctionFeb 12, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY COULD NOT ESTABLISH A TELEMETRY SESSION FOR THE IMPLANTABLE PULSE GENERATOR (IPG) WITH THEIR MONITOR. THE PATIENT WAS REFERRED TO THEIR CLINIC. THE DEVICE AND REMOTE MONITOR REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9702688 ↗
• MalfunctionFeb 11, 2020Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9691654 ↗
• MalfunctionAug 9, 2019Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  THE PATIENT REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) RESET WHEN THEY WERE NEAR THE METAL DETECTOR IN A STORE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8877804 ↗
• MalfunctionFeb 18, 2019Pacing Problem; Pacing Problem

  THE PATIENT REPORTED THEY "PUT OFF GETTING THEIR DEVICE CHECKED BECAUSE THE PAIN IS UNBEARABLE, I HAVE A GREAT DEAL OF DISCOMFORT EVERY TIME I HAVE MY DEVICE CHECK, I HAVE RESIDUAL DISCOMFORT FOR HOURS AFTER; IT FEELS BRUISED. THIS IS SOME OF THE WORST SENSATIONS I HAVE FELT IN MY LIFE". FOLLOW UP WITH THE PATIENT'S PHYSICIAN INDICATED THAT THE PATIENT HAS HIGH OUTPUT PACING WHEN A MAGNET IS APPLIED. THE PATIENT'S IMPLANTABLE PULSE GENERATOR REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Discomfort; Fatigue; Muscle Stimulation; Pain

  MAUDE report 8348890 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. 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 8231766 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED EROSION OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND TEMPORARY PACING WAS UTILIZED. A REPLACEMENT SYSTEM WAS LATER IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; No Code Available

  MAUDE report 7726249 ↗
• InjuryFeb 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT'S LEAD HAD DETERIORATED AND THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED PREMATURE BATTERY DEPLETION. ADDITIONAL INFORMATION OBTAINED FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A STEADY RISE OF IMPEDANCE AND THRESHOLD TO HIGH LEVELS, RESULTING IN A LEAD POLARITY SWITCH. THE LEAD LATER EXPERIENCED INTERMITTENT CAPTURE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254160 ↗
• InjuryJun 8, 2017Mechanical Problem; Capturing Problem; Device Sensing Problem; Mechanical Problem; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A PACING AND SENSING PROBLEM DUE TO A HEADER ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6627315 ↗
• InjuryJun 8, 2017Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT WITHIN ONE DAY POST-AV NODAL ABLATION, THE PATIENT EXPERIENCED PALPITATIONS AND A RACING HEART RATE. DURING A DEVICE CHECK, IT WAS NOTED THAT THE DEVICE WAS PACING ABOVE THE LOWER RATE EVEN THOUGH THE PATIENT WAS NOT ACTIVE. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations; Tachycardia

  MAUDE report 6624598 ↗
• DeathApr 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT HAD PASSED AWAY. THE SPOUSE REPORTED THAT AFTER THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED THE PATIENT "HAD AN INFECTION." THE SPOUSE ALSO MENTIONED THAT THE PATIENT HAD MANY OTHER PROBLEMS. FOLLOW UP WITH THE PATIENT'S CLINIC INDICATED THAT THEY HAD NO RECORDS REGARDING THE CIRCUMSTANCES OF THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS NOT NOTED IN THEIR RECORDS. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Death; Unspecified Infection

  MAUDE report 6512708 ↗
• MalfunctionApr 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THAT THEY EXPERIENCED PALPITATIONS AND DID NOT THINK THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS "OKAY". THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations

  MAUDE report 6470186 ↗

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-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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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-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-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,

…and 1 more.