ATTAIN® BIPOLAR OTW 419478 (UDI 00885074113364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 464 adverse event reports that list this exact device (DI 00885074113364), received between Apr 10, 2013 and Sep 28, 2026 — classified as 5 deaths, 310 injuries, 149 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (110 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 464 reports, 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 ↗
• 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 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 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 ↗
• 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 ↗
• MalfunctionMay 7, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND SLIGHTLY ELEVATED BIPOLAR PACING IMPEDANCE. IT WAS OBSERVED ON X-RAY THAT THE RV LEAD HELIX WAS LIKELY PERFORATED AND THERE WAS A POSSIBLY EXPOSED WIRE OR EXTERNALIZED CONDUCTOR FROM THE LEAD INSULATION. THE RV LEAD WAS CAPPED AND REPLACED. IT WAS ADDITIONALLY NOTED THAT THE PATIENT'S SYSTEM WITH THE RV LEAD WAS PROGRAMMED TO PACE AT FORTY BEATS PER MINUTE WITH ARRHYTHMIA DETECTIONS OFF VERSUS THE RV LEAD HAVING BEEN CAPPED AS PREVIOUSLY REPORTED. IT WAS LATER NOTED THAT THE RV LEAD WAS REMOVED. THE LEFT VENTRICULAR (LV) LEAD, WHICH WAS REMOVED DUE TO THE ASSOCIATED RV LEAD, HAD NO PRODUCT PERFORMANCE ALLEGATION BUT WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119746 ↗
• MalfunctionApr 29, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD AND LOSS OF CAPTURE. 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 25033106 ↗
• MalfunctionApr 29, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND BRADYCARDIA AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PACING BELOW THE LOWER RATE. THE CRTP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT PATIENT'S DEVICE TO INTERROGATE USING REMOTE MONITORING MOBILE APPLICATION THAT THEY RECEIVED A MESSAGE THAT SAID "FLASH BACK UP RESET". IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS. THE LV LEAD REMAINS IN USE. IT WAS NOTED THAT THE CRTP EXHIBITED NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033067 ↗
• MalfunctionMar 2, 2026Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISPLAYED HIGH OUTPUTS. 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 24488883 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING SEPTIC SHOCK AND A HEART FAILURE EXACERBATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 24309338 ↗
• InjuryFeb 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DAY AFTER IMPLANT, THE LEFT VENTRICULAR (LV) LEAD PULLED OUT OF THE CORONARY SINUS. THERE WAS AN ATTEMPT TO REPOSITION IT, BUT THE PHYSICIAN WAS UNABLE TO DO SO, SO THEY DECIDED TO REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240973 ↗
• MalfunctionJan 20, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA / ATRIAL FIBRILLATION (AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTEDAS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117812 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH VEGETATION NOTED ON THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A REPLACEMENT WAS IMPLANTED ONE WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24068661 ↗
• InjuryDec 17, 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 23829637 ↗
• MalfunctionDec 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAS EXHIBITED HIGH THRESHOLDS. 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 23803955 ↗
• MalfunctionDec 9, 2025Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT BI-VENTRICULAR (BI-V) CAPTURE COULD NOT BE CONFIRMED ON THE CURRENT ELECTROGRAM AND THE PATIENT WAS HAVING PAUSES. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23758177 ↗
• InjuryDec 4, 2025Capturing Problem; Capturing Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS PERFORMED TO INCREASE THE OUTPUT ON BOTH LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716310 ↗
• InjuryNov 18, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD 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 23586429 ↗
• InjuryNov 7, 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) PATIENT EXPERIENCED AN INFECTION. THE ORGANISMI WAS SPECIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS AND THE PATIENT ALSO EXPERIENCED BACTEREMIA AND VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 23501609 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) 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 23375728 ↗
• MalfunctionSep 19, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE FALLS. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall

  MAUDE report 23100952 ↗
• MalfunctionSep 19, 2025Low impedance; Adverse Event Without Identified Device or Use Problem; Low impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED TO A DIFFERENT PACING VECTOR DUE TO DIAPHRAGMATIC STIMULATION. FOLLOWING THE REPROGRAMMING, THE LV LEAD DEMONSTRATED LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED IMPEDANCE SPIKES AND VARYING IMPEDANCE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23099810 ↗
• InjurySep 16, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE. THE LEAD WAS REPROGRAMMED AND 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 23067171 ↗

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-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-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-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• 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-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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.