Adapta SRecalls & reported problems across all models

We found 6 models of Adapta S by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 305 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Apr 16, 2026 — classified as 41 deaths, 187 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (49 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Adapta S recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 17, 2019Open, Classified

   A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

   Z-0806-2019 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗

Most reported Adapta S problems

Adapta S models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Adapta™ S ADDRS1

  Pulse generator, permanent, implantable
  1 recall31 deaths117 reports
• Adapta™ S ADDRS1

  Implantable pulse generator, pacemaker (non-CRT)
  7 deaths142 reports
• Adapta™ S ADDRS1P

  Pulse generator, permanent, implantable
  1 recall1 death4 reports
• Adapta® S ADDRS1

  Pulse generator, permanent, implantable
  1 death35 reports
• Adapta™ S ADDRS1P

  Implantable pulse generator, pacemaker (non-CRT)
  1 death4 reports
• Adapta™ S ADDRS1P

  Implantable pulse generator, pacemaker (non-CRT)
  3 reports

Recent Adapta S adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Interrogate

  IT WAS REPORTED THAT THERE WAS NO TELEMETRY AS THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO BE INTERROGATED. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE WITH THE IPG. THE IPG REMAINS IN USE. THE PROGRAMMER IS EXPECTED TO BE RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894217 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS SPECIES. IT WAS NOTED THAT "FLUID" WAS EVIDENT ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER NOTED THAT THE IPG WAS THE CONTRIBUTING FACTOR.

  Patient problems: Bacterial Infection; Fluid Discharge; Sepsis; Unspecified Infection

  MAUDE report 24567079 ↗
• InjurySep 18, 2025Battery Problem; Battery Problem

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT'S "IMPLANTABLE PULSE GENERATOR (IPG) DIED". THE DEVICE 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 23082271 ↗
• MalfunctionJun 30, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT FELT THEIR HEART RATE LOWER TO FORTY BEATS PER MINUTE. THE 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: Bradycardia

  MAUDE report 22356087 ↗
• MalfunctionJun 24, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CAPTURE MANAGEMENT WENT UNEXPECTEDLY HIGH AND DEPLETED THE BATTERY. 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 22319188 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION, SEPSIS AND BACTEREMIA. THE SYSTEM WAS EXPLANTED AN REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 21933431 ↗
• DeathApr 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; WITH THE CAUSE OF DEATH COULD NOTED TO BE SEPSIS WITH ACUTE RESPIRATORY FAILURE. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

  Patient problems: Respiratory Failure; Sepsis; Septic Shock

  MAUDE report 21882008 ↗
• DeathOct 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY AND THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493385 ↗
• InjuryOct 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG WAS NOT EXPLANTED DUE TO THE CIRCUIT ERROR AND WAS EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344132 ↗
• InjuryOct 1, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS NOT INTERROGATABLE. THE IMPLANTABLE PULSE GENERATOR (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 20343980 ↗
• DeathSep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, A CAUSE OF DEATH COULD NOT BE IDENTIFIED. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20133347 ↗
• InjuryJul 3, 2024Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI)/ RECOMMENDED REPLACEMENT TIME (RRT) AND THE PATIENT EXPERIENCED SYNCOPAL EPISODES. THE IPG AS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 19665443 ↗
• InjuryJul 3, 2024Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THAT DURING THE UNRELATED PROCEDURE THE THE IPG EXHIBITED NON FUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 19664330 ↗
• MalfunctionApr 5, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS A POSSIBLE TELEMETRY ISSUE WITH 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 19049280 ↗
• MalfunctionMar 26, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED OVER-SENSING DURING A PROCEDURE. ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED. THE RIGHT ATRIAL (RA) LEAD EXHIBITED LEAD WARNING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM 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 18976870 ↗

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