Flexon 88862592-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521103757), received between Nov 26, 2018 and Jul 15, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE IN THE INTENSIVE CARE UNIT AFTER SURGERY, IT WAS DETERMINED AFTER A WHILE THAT THE PATIENT WAS BLEEDING. TO RESOLVE THE ISSUE, THE PATIENT WAS OPERATED AGAIN THAT EXTENDED THE SURGICAL TIME FOR 30 MINUTES OR MORE. DURING THE OPERATION, TEARS AND BLEEDING WERE DETECTED IN THE AREA WHERE THE PRODUCT WAS LOCATED. TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE BLEEDING WAS STOPPED WITH ANOTHER PRODUCT. THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 15032821 ↗
• MalfunctionOct 18, 2021Break; Product Quality Problem; Material Twisted/Bent; Break; Product Quality Problem; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIO SURGICAL TREATMENT IN A CHILD, THERE WAS TOO SOFT MATERIAL OF THE ELECTRODE MADE IT IMPOSSIBLE TO BEND IT INTO A HOOK FOR SEWING PURPOSES. THE STRAIGHT NEEDLE BENT INTO A HOOK AS IT PASSED THROUGH THE SKIN. THE SURGEON BROKE THE NEEDLE TO USE IT AS AN ELECTRODE HAD TO CUT IT WITH THE KNIFE. IT WAS NOTED THAT THE NEEDLE THAT WAS USED TO PASS THROUGH THE COATINGS HAD NO INCISION SO THAT IT CAN BE EASILY BROKEN. IT WAS NOTED THE OTHER TOOL GOT DAMAGED AND NOT CUT THE NEEDLES. THE USER WILL TRY TO REPLACE THE PRODUCT WITH A MORE CONVENIENT ONE FOR USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647940 ↗
• MalfunctionJun 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, THERE SHOULD BE 12 SUTURES IN A BOX, BUT ONLY 6 SUTURES WERE PRESENT. THIS WAS OBSERVED PRIOR TO SURGERY AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097387 ↗
• MalfunctionJul 29, 2020Break; Break

  ACCORDING TO THE REPORTER, POST-PACEMAKER SURGERY, THE THREAD WAS FOUND FRACTURED A FEW DAYS AFTER SURGERY.

  Patient problems: No Information

  MAUDE report 10341243 ↗
• MalfunctionNov 26, 2018Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT WAS INSTALLED WITH PACING LEAD TO PROTECT THE HEART RHYTHM DURING THE OPERATION. WHEN THE STATUS OF THE DEVICE WAS CHECKED THIS MORNING, IT WAS FOUND THAT THE SILVER NEEDLE AND THE PACEMAKER WERE BROKEN. IF THERE WAS AN ARRHYTHMIA OR CARDIAC ARREST OCCURRED, EFFECTIVE RESCUE WOULD NOT BE EXECUTED. THERE WAS NO PATIENT INJURY.

  Patient problems: Arrhythmia; Cardiac Arrest

  MAUDE report 8101890 ↗