FLEXI-TRAK 037449Recalls & reported problems
Convatec, Purchasing Department · Flexi-Trak® Anchoring Device - Lg · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455200658), received between May 11, 2022 and Sep 12, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of or Failure to Bond1
Patient problems
- Hypersensitivity/Allergic reaction1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED "EMERGENCY C SECTION MORNING OF (B)(6) 2023. SURGICAL DRESSING WAS REMOVED ON THE SECOND HOME VISIT FROM A MIDWIFE FROM THE HOSPITAL, 3 DAYS POST DELIVERY. WITHIN 12 HOURS AFTER THE DRESSING HAD BEEN REMOVED RASH APPEARED ON MY TORSO AND BACK WHICH HAD THE APPEARANCE OF BLISTERS (TORSO AREA AND INNER THIGH) AND A RED HIVE LIKE RASH OVER THE UPPER HALF OF MY BACK AND OVER BOTH SHOULDERS. THE RASH CONTINUED TO SPREAD UP THE NECK AND CHEST. WITHIN 24 HOURS THE RASH PIGMENTATION AROUND MY TORSO STARTED TO CHANGE TO A PURPLE COLOUR, WHICH PROGRESSIVELY GOT DARKER. MY SKIN FELT LIKE IT WAS BURNING, AND THE SKIN WAS INFLAMED SO MUCH THAT IT WAS RAISED, BUBBLY AND EXTREMELY HOT TO THE TOUCH. I WAS READMITTED TO SANDRINGHAM HOSPITAL AFTER VISITING A G.P WHOM INFORMED ME TO ATTEND EMERGENCY IMMEDIATELY. SEVERAL DOCTORS CONSULTED WITH ME AND DECIDED THAT I REMAIN UNDER HOSPITAL CARE UNTIL THEY COULD IDENTIFY WHAT THE SITUATION WAS. I WAS IN HOSPITAL FOR 5 DAYS (B)(6) 2023-(B)(6) 2023 AND UNABLE TO CARE FOR MY NEW BORN."
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17728122 ↗MalfunctionMay 11, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT IN THE PAST FLEXI-TRAK HAVE RESULTED IN SKIN TEARS OR HAVE DISLODGED AFTER 1-2 DAYS OF USE.
Patient problems: Laceration(s)
MAUDE report 14355652 ↗
Other Accessories, Catheter devices
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- Extension Set 456025B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Centeze Centesis Catheter DRC-002-06Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- Centeze Centesis Catheter DRC-002-05Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- IV Administration Set 490062B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Neff G10544Cook Incorporated · ACCESSORIES, CATHETER45 reports
- Cook G06299Cook Incorporated · ACCESSORIES, CATHETER18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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