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NA 5866-40MRecalls & reported problems

Medtronic, Inc. · ACCESSORY 5866-40M ADAPT 3.2MM LP IS-1 · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681490136952), received between Sep 14, 2018 and Sep 14, 2018 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Perforation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING LASER LEAD EXTRACTION FOR A SYSTEM UPGRADE, THE PATIENT REQUIRED OPEN HEART SURGERY TO REPAIR A SMALL TEAR IN THE RIGHT VENTRICLE. A NEW SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Perforation

    MAUDE report 7877348 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.