Catapult Guide Sheath 5F, 60cm, 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 04251244502065), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionOct 22, 2025Break; Break
THE PROBLEM IS DESCRIBED AS FOLLOWED: STANDARD LE ANGIOGRAM. 5FR CATAPULT INSERTED EASILY INTO PATIENT. DR. WENT IN WITH SERRENATOR CUTTING BALLOON AND AS THEY REMOVED IT THE BRAIDING OF THE SHEATH STARTED TO COME APART AS VISUALIZED UNDER FLURO. DR. HAD TO PARTIALLY REMOVE SHEATH AND GO BACK IN TO RETRIEVE THE REST OF THE SHEATH BRAIDING THAT WAS STILL IN THE BODY. PATIENT HAD SOME BLOOD LOSS BUT IS FULLY RECOVERED AND HOME. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE: REMOVAL OF SHEATH . WHAT IS THE NEXT COURSE OF ACTION? REPLACE PRODUCT PATIENT PRESENT AT TIME OF EVENT? YES PATIENT COMPLICATIONS: BLEEDING, 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? DEVICE BROKE IN PATIENT BODY- IT WAS FULLY REMOVED, BUT TOOK TIME AND CREATED SOME BLOOD LOSS MEDICAL OR SURGICAL INTERVENTIONS: REMOVAL OF SHEATH PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: NO PATIENT OUTCOME: FULLY RECOVERED. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVI
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23355600 ↗
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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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