Attesta™ L DR MRI SureScan™ ATDRL1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000316815), received between Jan 7, 2022 and Apr 9, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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 18, 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.

• MalfunctionApr 9, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG REMAINS IN USE. IT WAS NOTED THAT THE PROGRAMMER SOFTWARE WAS NOT THE LATEST. TROUBLESHOOTING STEPS WERE TAKEN TO UPDATE THE SOFTWARE USING A UNIVERSAL SERIAL BUS (USB); HOWEVER, THE ISSUE PERSISTED. AN ALTERNATIVE PROGRAMMER WAS USED TO INTERROGATE THE IMPLANTABLE DEVICE. THE PROGRAMMER 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 24829271 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD A COUPLE OF FALLS, ONE OF WHICH WAS AROUND THE TIME THE RV LEAD ISSUES BEGAN. ONE OF THE FALLS THE PATIENT FELL ON THEIR LEFT SHOULDER RESULTING IN ROTATOR CUFF TEARING. IT WAS ALSO NOTED THAT THE PATIENT WAS SYMPTOMATIC. THE RV LEAD FURTHER EXHIBITED LOSS OF CAPTURE. THE RA LEAD EXHIBITED INTERMITTENT CAPTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Fall; Palpitations; Unspecified Tissue Injury

  MAUDE report 24559894 ↗
• InjuryJun 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING AND THE RIGHT ATRIAL (RA) LEAD AND IPG WERE EXPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157249 ↗
• InjuryMay 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED SYMPTOMS FROM THE TELEMETRY. THE PATIENT CLAIMS THEY CAN TELL THEIR DEVICE IS OPERATING DIFFERENTLY AND FEELS SYMPTOMS WHEN COMMUNICATION SATELLITES GO OVER THEIR HOME. NO PERFORMANCE ISSUE WAS NOTED WITH THE IPG BUT, AS THE PATIENT DID NOT WANT TO HAVE A DEVICE, IT WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22000921 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO CONFIRM VENTRICULAR CAPTURE AND DID NOT APPEAR TO BE CAPTURING. THERE WERE POSSIBLE ISSUES OF VENTRICULAR OVERSENSING AND UNDERSENSING ON THE STORED ELECTROGRAM ON THE LEFT BUNDLE BRANCH RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THERE WAS HIGH THRESHOLDS ON THE LBB RV LEAD AND THE RV LBB LEAD WAS TWIDDLED. THE LBB RV LEAD AND THE IPG WERE EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Twiddlers Syndrome

  MAUDE report 21729862 ↗
• MalfunctionJul 11, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT BATTERY ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296791 ↗
• MalfunctionJan 7, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT BEFORE THE IMPLANT, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS TURNED ON BY CUSTOMER, SHOWS DATE DISCREPANCY AND FALSE ARRHYTHMIA LOG BOOK. IPG WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191831 ↗

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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• 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-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• 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-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 Numb
• 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 (
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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.