ATTAIN® BIPOLAR OTW 419488 (UDI 00885074113371)Recalls & reported problems

Summary

The FDA's MAUDE database contains 730 adverse event reports that list this exact device (DI 00885074113371), received between Dec 9, 2016 and Sep 16, 2026 — classified as 15 deaths, 493 injuries, 222 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (183 reports).

10 other recalls cover devices cleared under the same FDA submission (P010015); 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 25 most recent of 730 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764895 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 5, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE DEVICE INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF A NUMERICAL THRESHOLD VALUE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND CAPTURE WAS UNABLE TO BE CONFIRMED. THE LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082522 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 24995492 ↗
• InjuryApr 20, 2026Capturing Problem

  IT WAS REPORTED THAT THERE WAS A SUDDEN INCREASE IN LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEAD CAPTURE THRESHOLDS WITH CONTINUED GRADUAL INCREASES. THE RA AND LV LEADS WERE REPROGRAMMED AND REMAINED IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931923 ↗
• MalfunctionMar 24, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AND UNNECESSARY PACING AT TIMES. IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR PACING IMPEDANCES. THE RA LAND LV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676396 ↗
• InjuryMar 20, 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 SITE INFECTION AND EROSION. A BACK ABSCESS WAS NOTED AS THE SOURCE OF THE INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, PURULENT DISCHARGE AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Discomfort; Erosion; Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 24649172 ↗
• MalfunctionMar 3, 2026Failure to Capture; Extracardiac stimulation

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S), MISCLASSIFICATION OF EPISODES, AND UNNECESSARY PACING AT TIMES. IN ADDITION, THE LV LEAD EXHIBITED PHRENIC NERVE STIMULATION .25 ABOVE LOSS OF CAPTURE. THE RA AND LV LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24497338 ↗
• MalfunctionFeb 26, 2026High Capture Threshold

  IT WAS FURTHER NOTED THAT THE LV LEAD WAS OPTIMIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454610 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24392921 ↗
• InjuryFeb 6, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPAL EPISODES. IT WAS ALSO REPORTED THAT THE LV LEAD WAS SUSPECTED TO NOT HAVE BEEN CAPTURING DURING LV ONLY PACING. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN LV CAPTURE THRESHOLDS. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24280428 ↗
• MalfunctionFeb 2, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH RV THRESHOLD AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234531 ↗
• MalfunctionJan 16, 2026High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD TRENDS NOTED SPIKES FOR RV PACING IMPEDANCE, RV DEFIBRILLATION IMPEDANCE, AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. AN ALERT ALSO TRIGGERED FOR HIGH OUT OF RANGE SVC DEFIBRILLATION IMPEDANCE. IN ADDITION, LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE NOTED AS HISTORICALLY HIGH AND VARIABLE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24102976 ↗
• MalfunctionJan 6, 2026Low impedance

  IT WAS REPORTED THAT THERE WAS UNDERSENSING AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO LOW IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. 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 23974740 ↗
• MalfunctionJan 2, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT PRESENTED TO THE HOSPITAL BECAUSE OF THEIR LEADS AND NOTED ALARMS SOUNDING FROM THEIR DEVICE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943762 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23872056 ↗
• MalfunctionDec 10, 2025Degraded; Degraded

  THE LEAD WAS RETURNED AFTER THE PATIENT'S DEATH AND TESTED OUT OF SPECIFICATION. THE PATIENT DIED IN A MANNER UNRELATED TO THE DEVICE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767666 ↗
• InjuryNov 18, 2025Break; Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) AND INAPPROPRIATE ATRIAL PACING EVENT(S) AT TIMES. THE RA LEAD REMAINS IN USE. IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD WAS REPAIRED DUE TO INSULATION DAMAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582926 ↗
• InjuryNov 12, 2025Failure to Capture; Extracardiac stimulation; Low impedance; High Capture Threshold; Failure to Capture; Extracardiac stimulation; Low impedance; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE THREE LEADS HAD CHRONIC LOW IMPEDANCES AND THE LV LEAD HAD CHRONIC HIGH THRESHOLDS WITH NO OTHER OPTIONS FOR CHANGES DUE TO LOSS OF CAPTURE OR PHRENIC PACING WITH OTHER VECTORS. THE ONLY THING THAT WAS ABLE TO BE CHANGED WAS THE LV LEAD THRESHOLD OUTPUT, WHICH WAS DECREASED TO SAVE A LITTLE MORE BATTERY.

  Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535018 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010015. One submission often covers many models, so check the product and lot details in each record.

• 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-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-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2413-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2414-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2412-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2415-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.