Adapta™ ADSR03 (UDI 00613994222176)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994222176), received between Feb 8, 2018 and Apr 30, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Extracardiac stimulation” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT WHEN THE CAUTERY PEN CAME INTO CONTACT WITH THE IPG, VF OCCURRED AND THE IPG DID NOT EXHIBIT A PERFORMANCE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ventricular Fibrillation

  MAUDE report 21932951 ↗
• InjuryAug 25, 2023Extracardiac stimulation; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED POCKET STIMULATION FROM THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EXTRACARDIAC AND MUSCLE STIMULATION AND NOISE. CAPTURE MANAGEMENT WAS TURNED OFF. THE IPG AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 17622206 ↗
• InjuryMar 8, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT THE IPG HAD REACHED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS "COMPLETELY DEAD" AND COULD NOT BE INTERROGATED BY THE PROGRAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500917 ↗
• InjuryDec 29, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A GROMMET/SETSCREW PROBLEM. 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 16066434 ↗
• InjurySep 1, 2022Adverse 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) WAS EXPLANTED AND REPLACED AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15333841 ↗
• MalfunctionNov 3, 2021Pacing Problem; Missing Test Results; Pacing Problem; Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO PACING WITH MAGNET. IT WAS ALSO REPORTED THAT INTERMITTENT ABILITY TO INTERACT WITH THE DEVICE BY THE PROGRAMMER AND BATTERY VOLTAGE WAS UNAVAILABLE. IT WAS ALSO NOTED THAT THE PATIENT WAS LOST TO FOLLOW UP. 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 12749236 ↗
• MalfunctionJul 5, 2021Premature Discharge of Battery; Low impedance; Premature Discharge of Battery; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION AS A RESULT OF THE DEVICE BEING PROGRAMMED TO A HIGH OUTPUT AND ALSO THE LOW IMPEDANCE. BOTH THE LEAD 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 12116376 ↗
• InjuryFeb 8, 2018Unstable Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE EXHIBITED VARIATIONS IN CAPTURE MANAGEMENT. OUTPUT WAS INCREASED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 7256233 ↗

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-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-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-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-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-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-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-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.