FlexonRecalls & reported problems across all models

We found 6 models of Flexon by Covidien LP in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2018 and Sep 21, 2023 — classified as 2 deaths, 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Flexon problems

Flexon models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Flexon 8886259143-2

  ELECTRODE, PACEMAKER, TEMPORARY
  8 reports
• Flexon 88862589-63

  ELECTRODE, PACEMAKER, TEMPORARY
  2 deaths6 reports
• Flexon 88862592-43

  ELECTRODE, PACEMAKER, TEMPORARY
  5 reports
• Flexon 88862597-63

  ELECTRODE, PACEMAKER, TEMPORARY
  1 report
• Flexon 8886258643-2

  ELECTRODE, PACEMAKER, TEMPORARY
  1 report
• Flexon 8886259243-2

  ELECTRODE, PACEMAKER, TEMPORARY
  1 report

Recent Flexon adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY THE STRAIGHT METAL NEEDLE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. IT WAS ALSO REPORTED THE DEVICE FRAY AND LEAVE LITTLE PARTICLES ON GLOVES. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789158 ↗
• MalfunctionSep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STRAIGHT METAL NEEDLE OF THE DEVICE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THEY ARE UNABLE TO PACE AT THE BEDSIDE.

  Patient problems: Insufficient Information

  MAUDE report 17721548 ↗
• MalfunctionSep 8, 2023Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER POST-OPERATIVELY, THE CUSTOMER WAS COMPLAINING THAT THE STRAIGHT METAL NEEDLE OF THE DEVICE SEEMED TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE. A DEVICE SAMPLE WAS THEN TESTED POST-OPERATIVELY, SPUN THE WIRE OFF THE STRAIGHT NEEDLE AND IT CAME OFF. IT WAS ALSO REPORTED THAT THE DEVICE FRAY AND LEFT LITTLE PARTICLES ON HER GLOVES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713463 ↗
• MalfunctionSep 8, 2023Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER POST-OPERATIVELY, THE CUSTOMER IS COMPLAINING THAT THE STRAIGHT METAL NEEDLE OF ALL 3 DEVICE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE. A DEVICE SAMPLE WAS THEN TESTED POST-OPERATIVELY, SPUN THE WIRE OFF THE STRAIGHT NEEDLE AND IT CAME OFF. IT WAS ALSO REPORTED THE DEVICE FRAY AND LEAVE LITTLE PARTICLES ON HER GLOVES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713387 ↗
• MalfunctionSep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE WIRE BROKE OFF NEAR WHERE THE INSULATION WAS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695171 ↗
• MalfunctionSep 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STRAIGHT METAL NEEDLE SEEMS TO BE BREAKING OFF THE INSULATED WIRE.

  Patient problems: Insufficient Information

  MAUDE report 17674301 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CUSTOMER IS COMPLAINING THAT THE STRAIGHT METAL NEEDLE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE.

  Patient problems: Insufficient Information

  MAUDE report 17600172 ↗
• MalfunctionAug 18, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER POST-OPERATIVELY, THE CUSTOMER IS COMPLAINING THAT THE STRAIGHT METAL NEEDLE OF ALL 3 DEVICE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE. A DEVICE SAMPLE WAS THEN TESTED POST-OPERATIVELY, SPUN THE WIRE OFF THE STRAIGHT NEEDLE AND IT CAME OFF. IT WAS ALSO REPORTED THE DEVICE FRAY AND LEAVE LITTLE PARTICLES ON HER GLOVES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577239 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN AORTIC VALVE CHANGE, WHEN PLACING THE SUTURE AT THE CARDIAC VEIN, DUE TO THE CALIBER OF THE PACEMAKER WIRE, A LACERATION OF THE MAJOR CARDIAC VEIN WAS CAUSED IN THE POSTERIOR OF THE LEFT VENTRICLE, RESULTING IN ABUNDANT BLEEDING AND SUBSEQUENT PACKAGING. HOURS LATER, THE PATIENT UNDERWENT TWO RE-INTERVENTIONS AND ONE RE-INTERVENTION ON THE NEXT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 16151212 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE WIRE BREAKS WHERE THE WIRE CONNECTS TO THE GROUNDING POST.

  Patient problems: Insufficient Information

  MAUDE report 16071434 ↗
• MalfunctionDec 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A PEDIATRIC CARDIAC PROCEDURE, THE WIRE BREAKS WHERE THE WIRE CONNECTS TO THE GROUNDING POST.

  Patient problems: Insufficient Information

  MAUDE report 16062798 ↗
• MalfunctionDec 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN INTERNAL PACEMAKER PLACEMENT DUE TO THE PATIENT WAS IN COMPLETE HEART BLOCK, THE PACING WIRE BROKE. THE SURGEON HAD TO STRIP THE WIRES AND CONNECT PACING WIRES DIRECTLY INTO THE CABLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904256 ↗
• MalfunctionAug 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE BROKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287468 ↗
• 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 ↗

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