Advisa™ DR A4DR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169050730), received between Dec 9, 2016 and Sep 18, 2025 — classified as 4 injuries, 3 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY "HAVE BEEN FEELING ODD LATELY". THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOTED TO BE NOT PACING. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23082919 ↗
• InjuryDec 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED RAPID BATTERY DEPLETION DUE TO A LEAD ISSUE. 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 16003698 ↗
• InjuryMay 26, 2022Pacing Problem; Battery Problem; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TEN SECOND PAUSE WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED RECOMMENDED REPLACEMENT TIME (RRT). A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IMPLANTED WITH THE IPG REMAINING IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 14516262 ↗
• MalfunctionFeb 15, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED BITFLIP RESULTING INVALID DATA FOR PATIENT DATA ON THE CARELINK. THE IPG HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND 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 13535127 ↗
• MalfunctionJul 8, 2019Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED UNDERSENSING OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES FALLING INTO BLANKING PERIOD. 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 8766808 ↗
• InjuryOct 6, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE LONGEVITY WAS LOWER THAN EXPECTED GIVEN THE LOW OUTPUTS THAT THE IPG HAD BEEN PROGRAMMED. THE IPG 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 6920401 ↗
• InjuryDec 9, 2016Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available; Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PAST SEVERAL MONTHS, THE DEVICE HAS BEEN SWITCHED TO UNIPOLAR PACING ON THE RIGHT VENTRICULAR (RV) LEAD. A CHEST X-RAY WAS DONE THAT DID NOT SHOW ANY ABNORMALITIES ON THE LEAD SO THE CAUSE OF THE SWITCHES IS UNDETERMINED. SEVERAL PARAMETERS HAVE BEEN REPROGRAMMED IN RESPONSE TO THE POLARITY SWITCHES. THE RV LEAD AND THE DEVICE REMAIN IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 6160708 ↗

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-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-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-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.