Catapult Guide Sheath 5F, 90cm, straight, hydrophilic coatedRecalls & reported problems
Contract Medical International GmbH · Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. Introducer Sheath is hydrophilic coated on the distal end. · Class 2
All models of Catapult Guide Sheath (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04251244502072), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Separation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2024Fracture; Material Separation; Fracture; Material Separation
THE PROBLEM WAS DESCRIBED AS: "I DID NOTICE PHYSICIAN STRUGGLING TO ADVANCE SHEATH UPON INSERTION. WE DID NOT SEE ANY OBVIOUS ANATOMICAL CHALLENGES ON ANGIO. PHYSICIAN PERFORMED INTERVENTION SUCCESSFULLY. UPON REMOVAL, PHYSICIAN SAID THE SHEATH BECAME "STUCK" AND HE HAD TO USE FORCE TO PULL IT OUT AND THEN THE PLASTIC PORTION TORE AND THE BRAIDED PORTION BEGAN TO UNRAVEL. THE DOCTOR DECIDED TO USE A SCALPEL TO CUT THE SHEATH ABOVE THE DAMAGED PORTION IN ORDER TO INSERT A WIRE TO KEEP ACCESS. HE SUCCESSFULLY DID THIS AND WAS ABLE TO PUT A SHORT 7 FRENCH SHEATH IN. NO COMPLICATIONS, NOTHING LEFT INSIDE PATIENT. MINIMAL BLOOD LOSS." WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? HE TRIED TO INSERT A BALLOON IN TO TRAP HIS WIRE SO HE WOULDN'T LOSE ACCESS. THAT DID NOT WORK. PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: HEMATOMA, BLOOD LOSS / HEMORRHAGE IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? YES, PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION? PHYSICIAN SAID IT LOST ITS INTEGRITY AND BEGAN TO UNRAVEL. MEDICAL OR SURGICAL INTERVENTIONS: PH
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20289696 ↗
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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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