EXEL Safelet Catheter 26746Recalls & reported problems
Exel International · I.V. Catheter , 22G X 1 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10020221267461), received between Oct 30, 2025 and May 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Detachment of Device or Device Component1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Contamination
CUSTOMER REPORTED USING 22G CATHETERS AND WHEN THEY OPENED THE CAP FROM THE SEAL THERE WAS VISIBLE WATER/LIQUID. NO ADVERSE EVENT NOTED AS THE ISSUE WAS DISCOVERED BEFORE USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25246222 ↗MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE PLASTIC PART OF THE CATHETER (IN THE VEIN) WAS NOT PROPERLY CONNECTED TO THE EXTERNAL PLASTIC AND THE PATIENT (SEDATED FOR COHAT OR VETERINARY PET) BLED FROM THAT JUNCTION. OUR MAJOR CONCERN WAS THAT THE INTERNAL PORTION COULD HAVE BROKEN OFF AND CAUSED SERIOUS HARM OR DEATH TO THE PATIENT. WE NOTICED THE BLEEDING AROUND IT AND REMOVED THE CATHETER PROMPTLY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23428707 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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