ATTAIN® OTW 419378Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885074200729), received between Jul 13, 2017 and May 28, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV COIL IMPEDANCE AND HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE.  IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NO CAPTURE.  ADDITIONALLY, IT WAS REPORTED THAT THE RV PACE/SENSE LEAD EXHIBITED RISING THRESHOLDS.  THE RV LEAD, LV LEAD AND RV PACE/SENSE LEAD WERE EXPLANTED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320219 ↗
• MalfunctionDec 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT A LEAD IS ¿NOT FUNCTIONING APPROPRIATELY.¿ THE LEFT VENTRICULAR (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 23871187 ↗
• MalfunctionApr 29, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, UNDEFINED IMPEDANCE. 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 19204519 ↗
• MalfunctionAug 1, 2023High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND PREVIOUSLY EXPERIENCED PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED IMPEDANCE. IT WAS NOTED THAT THE LV LEAD PACING WAS ALREADY PROGRAMMED OFF. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Undesired Nerve Stimulation

  MAUDE report 17438358 ↗
• InjuryJul 17, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.  IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HISTORY OF HIGH THRESHOLD WITH PROGRAMMED HIGH OUTPUTS.  THE LV LEAD WAS CAPPED AND REMAINS IN THE PATIENT.  A NEW LV 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 17335986 ↗
• InjuryJun 13, 2023Intermittent Capture; High Capture Threshold; Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD AND CONSISTENT CAPTURE WAS UNABLE TO BE CONFIRMED. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED SYNCOPE AND A FALL AT HOME. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Syncope/Fainting

  MAUDE report 17122063 ↗
• InjuryMay 10, 2023High impedance; High Capture Threshold; Unstable Capture Threshold; High impedance; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRENDS SHOWED HIGH AND VARIABLE THRESHOLDS AND HIGH IMPEDANCE. 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 16907116 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15201017 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO AN INFECTION. A NEW SYSTEM WAS IMPLANTED FIVE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11387996 ↗
• InjurySep 11, 2019High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH AND INCREASING PACING IMPEDANCE, ALONG WITH A HIGH PACING THRESHOLD. THE LV LEAD WAS REPROGRAMMED AND IT WAS NOTED THE LEAD WOULD LIKELY BE REVISED AT THE TIME OF THE NEXT DEVICE REPLACEMENT. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8995794 ↗
• InjuryJul 11, 2019Capturing Problem; Capturing Problem

  IT WAS REPORTED BY A COMPETITOR THAT THE LEFT VENTRICULAR LEAD HAD A CAPTURE ANOMALY. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8783168 ↗
• InjuryApr 23, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT BOTH THE LEFT VENTRICULAR LEAD AND THE ATRIAL LEAD HAD HIGH THRESHOLDS. BOTH LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8540161 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH PACING THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. THE LEFT VENTRICULAR (LV) LEAD WAS CAUSING CHRONIC PHRENIC NERVE STIMULATION FOR THE PATIENT. THE LEAD WAS TURNED OFF AND WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Occlusion; Undesired Nerve Stimulation

  MAUDE report 8429060 ↗
• InjuryJan 30, 2019Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8290038 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF AND WAS CAPPED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 7695688 ↗
• InjuryMay 3, 2018Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT'S "WIRE BROKE" AND "THEY ARE MAD THAT A SECOND ONE HAS DONE THIS". IT WAS SUBSEQUENTLY REPORTED THAT THE LEFT VENTRICULAR LEAD WAS UNABLE TO CAPTURE AT HIGH OUTPUTS, HAD HIGH AND UNDEFINED IMPEDANCE AND A POSSIBLE FRACTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7484942 ↗
• InjuryApr 10, 2018Break; Break

  IT WAS REPORTED THAT THE DURING A DEVICE CHANGE THE TOP PORTION OF THE LEFT VENTRICULAR (LV) LEAD THAT CONNECTS TO THE DEVICE BROKE. THE LV LEAD WAS PARTIALLY REMOVED. THE REMAINING PORTION OF THE LV LEAD WAS CAPPED AND REMAINS IN THE PATIENT. A NEW CORONARY SINUS LEAD WAS ATTEMPTED BUT WAS UNABLE TO BE IMPLANTED DUE TO PATIENT ANATOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7415721 ↗
• InjuryJul 13, 2017Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT FUNCTIONING AS A LV LEAD AND IT WAS SUSPECTED THE LEAD HAD MOVED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711359 ↗

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-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-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.