Adapta LRecalls & reported problems across all models

We found 4 models of Adapta L by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,624 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2015 and Sep 18, 2026 — classified as 106 deaths, 882 injuries, 636 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (327 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 L 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 L problems

Adapta L models

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

• Adapta™ L ADDRL1

  Implantable pulse generator, pacemaker (non-CRT)
  20 deaths1,072 reports
• Adapta™ L ADDRL1

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 recall44 deaths200 reports
• Adapta™ L ADDRL1

  Pulse generator, permanent, implantable
  1 recall38 deaths177 reports
• Adapta® L ADDRL1

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths175 reports

Recent Adapta L adverse event reports

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

• MalfunctionSep 18, 2026Pacing Problem

  Patient problems: Discomfort

  MAUDE report 50825835 ↗
• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient's representative that the patient is "reacting badly" to the Implantable Pulse Generator (IPG) system with plans for a system revision. The IPG system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50671249 ↗
• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that by the patient's representative that during Implantable Pulse Generator (IPG) implant something was "nicked." The IPG was implanted and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50671214 ↗
• InjurySep 3, 2026Pacing Problem

  It was reported that the patient experienced chest pain. It was noted that the Implantable Pulse Generator (IPG) had reached Elective Replacement Indicator (ERI). It was also reported that the patient experienced a heart rate below the programmed lower rate limit of the IPG. The patient was admitted to hospital. The IPG remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Chest Pain

  MAUDE report 50588276 ↗
• InjurySep 1, 2026Electromagnetic Interference; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540678 ↗
• MalfunctionAug 28, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507777 ↗
• InjuryAug 25, 2026Premature Discharge of Battery

  It was reported that the epicardial Right Ventricular (RV) lead exhibited rising and high thresholds resulting in the ventricular pacing output increasing to 5.0 Volts at 1.0 milliseconds, increasing pacing output, resulting in increased battery utilization and contributed to the Implantable Pulse Generator (IPG) reaching Recommended Replacement Time (RRT) sooner than previously estimated. The IPG was explanted. The RV lead was capped and remains in the patient. A leadless IPG was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430959 ↗
• MalfunctionAug 12, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219227 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced infection. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50214853 ↗
• MalfunctionAug 6, 2026Reset Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157217 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced syncope. The Implantable Pulse Generator (IPG) system remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50050942 ↗
• MalfunctionJun 30, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE CONCERNED ABOUT THEIR IMPLANTABLE PULSE GENERATOR (IPG) LONGEVITY. 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 25665898 ↗
• MalfunctionJun 30, 2026Output Problem

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD SLIGHTLY ELEVATED OUTPUTS, RESULTING IN DECREASE IN BATTERY ESTIMATE SINCE THE LAST CARELINK TRANSMISSION. 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 25665756 ↗
• MalfunctionJun 11, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO BE INTERROGATED. 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 25469497 ↗
• MalfunctionJun 4, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CAPTURE MANAGEMENT HAS BEEN OBSERVED TO INTERMITTENTLY SWITCH TO HIGH PACING OUTPUTS, WHICH CAN LEAD TO EXCESSIVE BATTERY DEPLETION. THE IMPLANTABLE PULSE GENERATOR (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 25393080 ↗

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