ATTAIN BIPOLAR OTWRecalls & reported problems across all models

We found 4 models of ATTAIN BIPOLAR OTW by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,198 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2013 and Sep 28, 2026 — classified as 20 deaths, 806 injuries, 372 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (294 reports).

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

Most reported ATTAIN BIPOLAR OTW problems

ATTAIN BIPOLAR OTW models

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

• ATTAIN® BIPOLAR OTW 419488

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  15 deaths730 reports
• ATTAIN® BIPOLAR OTW 419478

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  5 deaths464 reports
• ATTAIN® BIPOLAR OTW 419488

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  3 reports
• ATTAIN® BIPOLAR OTW 419478

  permanent pacemaker Electrode
  1 report

Recent ATTAIN BIPOLAR OTW adverse event reports

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

• MalfunctionSep 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924234 ↗
• MalfunctionSep 16, 2026Failure to Capture; Pacing Problem

  It was reported that the Left Ventricular (LV) lead experienced potential loss of capture or ineffective pacing. The lead 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 50790437 ↗
• MalfunctionSep 9, 2026Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681190 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection with noted vegetation. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50439846 ↗
• MalfunctionAug 24, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421462 ↗
• MalfunctionAug 13, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237644 ↗
• MalfunctionAug 13, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232518 ↗
• MalfunctionJul 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764895 ↗
• MalfunctionJul 1, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VENTRICULAR DOUBLE COUNTING. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR LVRING TO RVCOIL IMPEDANCE THAT WAS LOWER THAN THE PROGRAMMED THRESHOLD. THE LV LEAD 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 25679120 ↗
• InjuryJun 25, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IN USE FOR PACING AND SENSING EXHIBITED HIGH THRESHOLDS AND HIGH UNDEFINED IMPEDANCE. IT WAS REPORTED THAT THE RV LEAD IN USE FOR DEFIBRILLATION EXHIBITED HIGH UNDEFINED IMPEDANCE ON BOTH DEFIBRILLATION COILS. THE LEADS WERE CAPPED AND A NEW LEAD WAS IMPLANTED FOR PACING AND DEFIBRILLATION. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. THE LEAD WAS CAPPED WITH NO REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620308 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT DUE TO INFECTION WITH EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 25612470 ↗
• MalfunctionJun 24, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD CAPTURE THRESHOLD WAS INTERMITTENTLY ABOVE THE PROGRAMMED OUTPUT. THE LV LEAD 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 25612357 ↗
• DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH EROSION AND PURULENT DISCHARGE OBSERVED. DURING THE ATTEMPTED EXPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE PATIENT EXPIRED DURING EXTRACTION OF THE RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THAT THE OTHER TWO LEADS WERE SUCCESSFULLY REMOVED, HOWEVER THE RA LEAD CAUSED A COMPLICATION. IT WAS NOTED THAT DURING RIGHT ATRIAL LEAD EXTRACTION, IT WAS PERCEIVED THAT A PERFORATION WAS CREATED WHEN THE ATRIAL LEAD WAS REMOVED.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 25446546 ↗
• MalfunctionJun 5, 2026High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE CRTD WAS EXPLANTED AND REPLACED AND THE LV LEAD 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 25414465 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE SYSTEM INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25143926 ↗

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