ATTAIN® OTW 419388Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00885074200736), received between Aug 8, 2014 and Aug 5, 2026 — classified as 52 injuries, 17 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (25 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Fracture; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead had fractured. Lead impedance had risen to a high undefined range and capture thresholds had risen to a high range. The lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143906 ↗
• InjuryJul 29, 2026Intermittent Capture; Capturing Problem; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited  high and rising LV threshold ad intermittent LV capture. The lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074721 ↗
• InjuryFeb 17, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE, UNDEFINED DEFIBRILLATION IMPEDANCE AND INCREASING THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT-OF-RANGE, LOW PACING IMPEDANCE. THE LEADS WERE EXTRACTED AND REIMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369647 ↗
• InjuryJan 23, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THAT THE PACE/SENSE RIGHT VENTRICULAR (RV) LEAD HAD LOW PACING IMPEDANCE, HIGH THRESHOLDS WITH NO CAPTURE AND THE INABILITY TO SENSE APPROPRIATELY. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS WITH LOSS OF CAPTURE. THE PATIENT WAS HOSPITALIZED. THE PACE/SENSE RV LEAD WAS TAKEN OUT OF SERVICE AND THE LV LEAD 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 24162390 ↗
• InjuryOct 24, 2025Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH IMPEDANCE, HIGH THRESHOLDS AND NO CAPTURE. THE LV 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 23384995 ↗
• MalfunctionOct 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW AND DECREASING IMPEDANCE. IT WAS FURTHER REPORTED THAT APPROXIMATELY SIX YEARS LATER, THE RA LEAD EXHIBITED LOW IMPEDANCE IN ADDITION TO UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES AND ALSO APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE PATIENT¿S LEFT VENTRICULAR (LV) TRIGGERED SEVERAL ALERTS FOR UNDEFINED HIGH PACING IMPEDANCE. 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 23342507 ↗
• InjuryJul 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH PACING THRESHOLDS. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED WITH A LEFT BUNDLE BRANCH AREA PACING LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413958 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF DUE TO DIAPHRAGMATIC STIMULATION THAT COULD NOT BE PROGRAMMED AROUND. APPROXIMATELY 13 YEAR LATER, THE LV LEAD WAS CAPPED AND UNUSABLE. THE LEAD WAS ULTIMATELY EXPLANTED APPROXIMATELY 4 YEARS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 21868366 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LESS THAN 1 MONTH POST ROUTINE GENERATOR REPLACEMENT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION AND EROSION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED UNTIL A NEW CRT-D SYSTEM WAS IMPLANTED 15 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21697366 ↗
• InjuryJan 23, 2025High impedance; Low impedance; Capturing Problem; Impedance Problem; High impedance; Low impedance; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING IMPEDANCE THAT WAS ALSO FLUCTUATING BETWEEN HIGH AND LOW. PACING THRESHOLDS WERE ALSO NOTED TO HAVE INCREASED OVER TIME. 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 21221261 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WITH EVIDENCE OF VEGETATION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21116218 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER A GENERATOR CHANGEOUT PROCEDURE, WOUND DEHISCENCE AND DRAINAGE WERE NOTED AT THE INCISION SITE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. A POCKET INFECTION WAS NOTED WHICH REQUIRED A POCKET REVISION PROCEDURE. THE PATIENT EXPERIENCED DISCOMFORT AND EROSION AS A RESULT. INTRAVENOUS (IV) AND TOPICAL ANTIBIOTICS WERE ADMINISTERED AS WELL AS PAIN MEDICATION. THE CRT-D SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 20759125 ↗
• InjuryNov 5, 2024High impedance; High impedance

  IT WAS LATER REPORTED THAT THE LV LEAD WAS PROGRAMMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611258 ↗
• InjuryOct 11, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT DURING A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPLACEMENT PROCEDURE THE PATIENT EXPERIENCED ASYSTOLE. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD DID NOT CAPTURE WHEN IT WAS PLACED BACK INTO THE HEADER OF THE CRT-D. WHEN THE RV LEAD WAS REMOVED FROM THE HEADER THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED LOSS OF CAPTURE DUE TO THE PROGRAMMING CONFIGURATION, THE LV LEAD WAS PROGRAMMED LV TO RV TIP. IT WAS SUSPECTED THAT THE RV LEAD PIN MAY NOT HAVE BEEN INSERTED ALL THE WAY BACK IN THE HEADER WHEN THE LOSS OF CAPTURE REMAINED. THE CRT-D REPLACED WAS COMPLETED AND THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 20429244 ↗
• InjuryJul 24, 2024High impedance; Impedance Problem; High Capture Threshold; Unstable Capture Threshold; High impedance; Impedance Problem; High Capture Threshold; Unstable Capture Threshold

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD RISING, VARYING AND HIGH IMPEDANCE MEASUREMENTS WITH V ARIABLE/HIGH THRESHOLD MEASUREMENTS. IT WAS NOTED THAT THE IMPEDANCE MEASUREMENTS TRIGGERED A LEAD WARNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822338 ↗
• MalfunctionJun 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT ONE OF THEIR LEADS HAS BEEN DRAINING THE COMPETITOR DEVICE BATTERY ALL OF THE TIME. 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 19636673 ↗
• InjuryJun 12, 2024Failure to Capture; Fracture; Capturing Problem; Impedance Problem; Failure to Capture; Fracture; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING THRESHOLDS, NO LV CAPTURE, AND A SPIKE IN LV PACING LEAD IMPEDANCE. THERE WAS A CONFIRMED FRACTURE ON THE LOW VOLTAGE PORTION OF THE LEAD. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521684 ↗
• MalfunctionMay 17, 2024High impedance; High impedance

  IT WAS FURTHER REPORTED THAT A LEAD REVISION WAS PERFORMED. HIGH VOLTAGE THERAPIES WERE PROGRAMMED OFF AND THE LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345405 ↗
• InjuryMay 1, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT DURING USE THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FALLING LV PACING IMPEDANCE. THE LV LEAD WAS NO LONGER FUNCTIONAL, AND NOT DEEMED NECESSARY FOR PATIENT. THE LV LEAD WAS CAPPED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221845 ↗
• InjuryMar 30, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONIC NO CAPTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009190 ↗
• MalfunctionFeb 28, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND CAPTURE COULD NOT BE CONFIRMED. THE RV AND 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 18797585 ↗
• MalfunctionJan 26, 2024High impedance; Low impedance; Impedance Problem; High impedance; Low impedance; Impedance Problem

  IT WAS REPORTED THAT DURING USE OF THE LEFT VENTRICULAR (LV) LEAD AN ALERT TRIGGERED FOR HIGH IMPEDANCE, LV TIP TO RIGHT VENTRICULAR COIL.  THE LV LEAD REMAINS IN USE.  ADDITIONALLY, DURING USE OF THE RIGHT ATRIAL (RA) LEAD AN ALERT TRIGGERED FOR HIGH IMPEDANCE.  THE RA LEAD REMAINS IN USE.  AN ALERT TRIGGERED FOR RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE.  THE RV LEAD REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LV LEAD IMPEDANCE HAD BEEN SLOWLY INCREASING. THE CLINIC NOTED THAT THEY WERE MONITORING THE LEAD AND HAD PLANNED TO INCREASE THE WARNING VALUE ON THE LV IMPEDANCE ALERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589938 ↗
• MalfunctionDec 19, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FLOOR WITH SHORTNESS OF BREATH.  IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS.  HOWEVER, THIS IS CONSISTENT WITH HISTORIC MEASURES.  THE LEAD REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 18357313 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN IMPLANT SITE THAT APPEARED TO BE INFECTED AND THERE WAS AN EXPOSED LEAD COMING OUT DUE TO EROSION. AN INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) NOTED OCCASIONAL UNDERSENSING BY THE RIGHT ATRIAL (RA) LEAD. THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT. THE PATIENT WAS STARTED ON ANTIBIOTICS AND THE CRT-D SYSTEM WAS REMOVED THREE DAYS LATER. A NEW SYSTEM WAS IMPLANTED THREE DAYS POST-SYSTEM EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Pain; Unspecified Infection

  MAUDE report 18345754 ↗
• MalfunctionMay 11, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD SUSPECTED 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 16911337 ↗

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-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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.