ATTAIN® BIPOLAR OTW 419488 (UDI 00643169590588)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169590588), received between Apr 6, 2017 and Apr 13, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2021Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS AND OCCASIONAL LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AT MAXIMUM OUTPUTS. IT WAS FURTHER NOTED THAT THE PATIENT WAS EXPERIENCING DIZZINESS. THE LV LEAD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 11657591 ↗
• MalfunctionApr 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING IMPLANT THE LEFT VENTRICULAR (LV) LEAD DISLODGED DUE TO PATIENT ANATOMY. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7459292 ↗
• InjuryApr 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO DAYS AFTER IMPLANT, THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LV LEAD WAS 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 6466406 ↗

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