Adapta® ADSR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169474208), received between Feb 9, 2017 and Mar 30, 2026 — classified as 11 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (6 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. 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 24730203 ↗
• MalfunctionFeb 23, 2026Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED INTERRUPTED TELEMETRY. IT WAS FURTHER REPORTED THE DEVICE EXHIBITED A PAUSES.  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 24412693 ↗
• MalfunctionJul 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAS NOT BEEN ABLE TO SEND A REMOTE TRANSMISSION IN A FEW YEARS. IT WAS DISCOVERED ON AN IN PERSON TRANSMISSION THAT THE NUMBERS ON THE IPG SERIAL NUMBER WERE CHANGED TO ALL ZEROS. IT WAS FURTHER REPORTED THAT THE IPG HAS SUBSEQUENTLY SENT A SUCCESSFUL TRANSMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586776 ↗
• MalfunctionJul 9, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT PATIENT'S REPRESENTATIVE STATED DID NOT RECEIVED REMOTE MONITORING NETWORK TRANSACTION (TXS) YET. TICKET WAS CREATED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED TELEMETRY ISSUES. 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 22457865 ↗
• MalfunctionNov 14, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PERFORMANCE ISSUE WITH THE IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130669 ↗
• MalfunctionJul 25, 2023Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 17389279 ↗
• MalfunctionJan 31, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THERE WAS POSSIBLE ELECTROMAGNETIC INTERFERENCE/NOISE NOTED ON STORED ELECTROGRAMS (EGM) THAT WAS NOT SENSED BY THE IMPLANTABLE PULSE GENERATOR (IPG). 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 16270522 ↗
• MalfunctionJan 6, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A POSSIBLE ELECTROGRAM (EGM) STORAGE MALFUNCTION. 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 16112112 ↗
• MalfunctionDec 1, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND HEART RATE OF 45BPM. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE PROGRAMMED RATE AND THE PATIENT "WAS NOT PALPATING AT THE TIME". 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 12907046 ↗
• InjuryNov 23, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND PAUSES. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PACING PAUSES LASTING APPROXIMATELY THREE TO FOUR SECONDS. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes; Syncope/Fainting

  MAUDE report 10883571 ↗
• MalfunctionJun 25, 2020Pacing Problem; Pacing Problem

  THE PATIENT REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) IS "FIRING." THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194070 ↗
• InjuryMay 1, 2020Signal Artifact/Noise; Electromagnetic Interference; Mechanical Problem; Signal Artifact/Noise; Electromagnetic Interference; Mechanical Problem

  IT WAS REPORTED THAT NOISE WAS NOTED ON THE DEVICE. THE LEAD TESTED FINE AND GROMMET/SET SCREW PROBLEM WAS SUSPECTED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED 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 10017084 ↗
• MalfunctionOct 22, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT POSSIBLE LOSS OF TELEMETRY WAS NOTED. THE IMPLANTABLE PULSE GENERATOR (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 9217359 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXTRACTED DUE TO INFECTION. THE DEVICES WERE LATER REPLACED WITH THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8670449 ↗
• MalfunctionMay 1, 2019Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN ATRIAL TACHYCARDIA. UNDERSENSING DUE TO EVENTS FALLING WITHIN THE ATRIAL REFRACTORY AND BLANKING PERIOD WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG). INTERMITTENT FAR FIELD R-WAVE OVERSENSING WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE IPG AND RA LEAD 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 8568619 ↗
• MalfunctionJan 28, 2019Communication or Transmission Problem; Communication or Transmission Problem

  THE PATIENT REPORTED THAT "MY TRANSMISSIONS HAVE NOT BEEN RECEIVED". THEY ALSO REPORTED THAT THEY HAVE BEEN HAVING "FREQUENT NAUSEA SPELLS AND OUT OF BREATH" WHEN THEY CLIMB THE STAIRS. THEY STATED " I AM CONCERNED THERE IS SOMETHING WRONG WITH MY HEART CONTROL, OR MY GENERAL HEALTH". THE PATIENT'S IMPLANTABLE PULSE GENERATOR REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined; Dyspnea; Nausea

  MAUDE report 8281418 ↗
• MalfunctionMay 8, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE PULSE GENERATOR (IPG) HAD LOW BATTERY VOLTAGE. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7495646 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7476415 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH A FEVER AND SIGNS OF AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 7417822 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED DUE TO INFECTION. THE SYSTEM WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7413976 ↗
• InjuryApr 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THAT FOR THE PAST TWO AND A HALF WEEKS, THEY "HAVE PAIN IN THE AREA AND THE DEVICE HAS MOVED OUT OF PLACE. I'M NOT GETTING MUCH SLEEP BECAUSE OF IT". IN ADDITION, THE PATIENT INDICATED THAT THEY WENT TO THE DOCTOR'S OFFICE, AND WAS TOLD "IT WAS NORMAL, THE DEVICE HASN'T MOVED BUT THE SCAR TISSUE HAD". FOLLOW-UP INVESTIGATION WITH THE CLINIC REVEALED THAT THE DOCTOR CHOSE TO REPOSITION THE PACEMAKER IN HOPES OF ALLEVIATING THE PATIENT'S PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 7413866 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 7412038 ↗
• MalfunctionFeb 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT PREOPERATIVELY, AN INTERROGATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOUND THAT THE LONGEVITY UNEXPECTED AT 5.5 YEARS. IT WAS NOTED THAT THE DEVICE WAS NOT STORED NEAR A MAGNET OR IN THE COLD. THE IPG WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7253901 ↗
• MalfunctionDec 7, 2017Signal Artifact/Noise; Electromagnetic Interference; Under-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE SHOWED UNDERSENSING OF NOISE SIGNAL ON THE VENTRICULAR ELECTROGRAM DUE TO ELECTROMAGNETIC INTERFERENCE AT TIME OF A SURGERY WHEN THE ELECTRODE WAS BEING STIMULATED. 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 7092521 ↗
• MalfunctionOct 6, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG), THREE DIFFERENT WRENCHES BECAME STUCK INSIDE THE DEVICE HEADER GROMMET AND FAILED TO SET THE SCREW. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919994 ↗

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-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-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-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-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.