Adapta™ ADSR03 (UDI 00643169708846)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169708846), received between Jan 8, 2020 and Sep 11, 2025 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 23026757 ↗
• MalfunctionNov 24, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED "JUMPING IN THEIR CHEST THAT WAS EQUAL TO THEIR HEART RATE AND WAS LIKE HYPERVENTILATION WHEN LYING ON THEIR LEFT SIDE". IT WAS ALSO REPORTED BY THE PATIENT THAT THEY EXPERIENCED PAIN OR DISCOMFORT. IT WAS ALSO REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Discomfort; Hyperventilation; Pain

  MAUDE report 15860789 ↗
• DeathSep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED BY THE PHYSICIAN THAT THE CAUSE OF DEATH WAS DEFINED AS CARDIAC ARREST. IT WAS ALSO CONFIRMED BY THE PHYSICIAN THAT THE PATIENT DEATH WAS NOT RELATED TO THE DEVICE SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 12513204 ↗
• MalfunctionMay 5, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS FURTHER REPORTED THAT THE DEVICE HAD PREVIOUSLY TRIPPED FROM AOO TO VVI AND THE PATIENT HAD BECOME SYMPTOMATIC, AND THE SENSITIVITY LEVELS WERE INCREASED. THE SENSITIVITY LEVELS WILL BE REVIEWED AGAIN TO MEASURE BATTERY MEASUREMENTS AT THE NEXT CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775854 ↗
• MalfunctionMar 4, 2021Pacing Problem; Impedance Problem; Data Problem; Pacing Problem; Impedance Problem; Data Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS FURTHER SEEN IN THE CLINIC, THE DEVICE WAS REPROGRAMMED AND THE PHYSICIAN WAS SATISFIED WITH THE LONGEVITY ESTIMATE WITH THE INCREASED IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411536 ↗
• MalfunctionAug 4, 2020Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT PATIENT DIDN'T PRESENT WITH A LACK OF PACING, THEY CAME IN WITH A REPORTED FAST RHYTHM THAT PREVENTED THE CLINICAL STAFF FROM EVER SEEING IF THE PACER PACED.

  Patient problems: Arrhythmia; Syncope

  MAUDE report 10361195 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECRTION OF THEIR PACEMAKER POCKET. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9564054 ↗

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-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-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-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-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-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.