Flexima™ M001271860Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729323372), received between Aug 21, 2019 and Oct 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionOct 15, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17SEP2025. IT WAS REPORTED THAT THE SHEATH BUCKLED. A VTC/8/K FLEXIMA REGULAR WAS SELECTED FOR A NEPHROSTOMY PROCEDURE. DURING PREPARATION, THE 0.018 WIRE SNAGGED WITHIN THE THREE-PART NEEDLE SHEATH AND CAUSED DAMAGE TO THE DEVICE ITSELF. THE VTC/8/K FLEXIMA REGULAR WAS NOT USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE RADIOPAQUE MARKER WAS TORN AT THE MIDDLE TO TIP SECTION OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302274 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE RADIOPAQUE MARKER DETACHED. A VTC/8/K FLEXIMA REGULAR WAS SELECTED FOR USE. DURING PROCEDURE, THE RADIOPAQUE MARKER BECAME DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919075 ↗