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FlexCath Advance™ 990065Recalls & reported problems

Medtronic, Inc. · SHEATH 990065 FLEXCATH SELECT 10 FR 65CM · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000279905), received between Nov 10, 2020 and Aug 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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

  • Material Twisted/Bent2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 15, 2022Material Twisted/Bent; Material Twisted/Bent

    AFTER A COMPLETED CASE, THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15226536 ↗
  • MalfunctionNov 10, 2020Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING A RADIOFREQUENCY PROCEDURE, A SHEATH KINK WAS NOTED. THE SHEATH WAS REPLACED WITH RESOLUTION. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10817375 ↗

Other CATHETER, STEERABLE devices

All CATHETER, STEERABLE devices →

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