AdaptaRecalls & reported problems across all models

We found 27 models of Adapta by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,987 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2014 and Sep 28, 2026 — classified as 191 deaths, 1,667 injuries, 1,129 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (537 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 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 5 of these models · Recall details · FDA record ↗

Most reported Adapta problems

Adapta models

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

• Adapta™ ADDR01

  Implantable pulse generator, pacemaker (non-CRT)
  39 deaths1,801 reports
• Adapta™ ADDR01

  Pulse generator, permanent, implantable
  1 recall84 deaths364 reports
• Adapta™ ADSR01

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths237 reports
• Adapta® ADDR01

  Pulse generator, permanent, implantable
  7 deaths229 reports
• Adapta™ ADDR01

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall47 deaths161 reports
• Adapta™ ADDR06

  Pulse generator, permanent, implantable
  1 recall2 deaths7 reports
• Adapta™ ADDR03

  Pulse generator, permanent, implantable
  1 recall1 death6 reports
• Adapta™ ADVDD01

  Pulse generator, permanent, implantable
  1 recall1 report
• Adapta™ ADSR01

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  36 reports
• Adapta® ADSR01

  Pulse generator, permanent, implantable
  32 reports
• Adapta™ ADDR03

  Pulse generator, permanent, implantable
  1 death26 reports
• Adapta™ ADSR06

  Implantable pulse generator, pacemaker (non-CRT)
  20 reports
• Adapta™ ADDR06

  Pulse generator, permanent, implantable
  1 death13 reports
• Adapta™ ADSR01

  Implantable pulse generator, pacemaker (non-CRT)
  12 reports
• Adapta™ ADSR03

  Pulse generator, permanent, implantable
  8 reports
• Adapta™ ADSR03

  Implantable pulse generator, pacemaker (non-CRT)
  1 death7 reports
• Adapta® ADDR06

  Pulse generator, permanent, implantable
  6 reports
• Adapta™ ADDR06

  Implantable pulse generator, pacemaker (non-CRT)
  5 reports
• Adapta™ ADSR01P

  Pulse generator, permanent, implantable
  3 reports
• Adapta™ ADDR03

  Implantable pulse generator, pacemaker (non-CRT)
  3 reports
• Adapta® ADDR03

  Implantable pulse generator, pacemaker (non-CRT)
  2 reports
• Adapta™ ADSR06

  Implantable pulse generator, pacemaker (non-CRT)
  2 reports
• Adapta™ ADSR06

  Implantable pulse generator, pacemaker (non-CRT)
  2 reports
• Adapta™ ADVDD01

  Pulse generator, permanent, implantable
  1 report
• Adapta® ADVDD01

  Pulse generator, permanent, implantable
  1 report
• Adapta™ ADVDD01

  Implantable pulse generator, pacemaker (non-CRT)
  1 report
• Adapta™ ADSR03

  Pulse generator, permanent, implantable
  1 report

Recent Adapta adverse event reports

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

• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Implantable Pulse Generator (IPG) was not functioning within normal limits. 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 50913408 ↗
• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Syncope/Fainting

  MAUDE report 50912134 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50895752 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The organism was identified as Enterococcus faecalis. It was further noted that the patient experienced bacteremia and discomfort.  The patient was administered antibiotics. The IPG system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Discomfort; Unspecified Infection

  MAUDE report 50882046 ↗
• MalfunctionSep 16, 2026Device-Device Incompatibility

  It was reported by the patient that they experienced high blood pressure and not feeling well after an Magnetic Resonance Imaging (MRI) scan. It was also noted that the Implantable Pulse Generator (IPG) is not labelled for MRI. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 50785884 ↗
• InjurySep 14, 2026Premature Discharge of Battery

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. 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 50750368 ↗
• InjurySep 11, 2026Premature Discharge of Battery

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. It was also reported that the Right Atrial (RA) lead displayed low impedance and Right Ventricular (RV) lead exhibited rising thresholds. The IPG was explanted and replaced. Both the leads 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 50733940 ↗
• MalfunctionSep 10, 2026Pacing Problem

  It was reported by the patient that they experienced bradycardia. The patient noted that they feel the Implantable Pulse Generator (IPG). The IPG was reported to be pacing below the lower rate. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50712739 ↗
• InjurySep 9, 2026Premature Discharge of Battery; Pacing Problem

  It was reported that the patient experienced bradycardia, pre-syncope and shortness of breath. It was further reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion and a pacing problem. It was further noted that the Right Ventricular (RV) lead exhibited high impedance, polarity switch and loss of capture. The IPG was explanted and the RV lead was capped. No patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dyspnea; Presyncope

  MAUDE report 50688440 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647327 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Pulse Generator (IPG) system was explanted due to an infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50451166 ↗
• MalfunctionAug 25, 2026Electromagnetic Interference

  It was reported that the patient experienced Atrial Fibrillation (AF) and the device exhibited Electromagnetic Interference. The device remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Atrial Fibrillation

  MAUDE report 50431217 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection in the abdomen with erosion, discomfort, fever, purulent discharge/pus, redness and swelling. The Implantable Pulse Generator (IPG) was explanted and replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erosion; Erythema; Fever; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 50427344 ↗
• MalfunctionAug 18, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296471 ↗
• MalfunctionAug 7, 2026Pacing Problem

  Patient problems: Bradycardia; Dizziness

  MAUDE report 50174349 ↗

Other Medtronic, Inc. products

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