Catapult Guide Sheath 6F, 60cm, straight, hydrophilic coatedRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04251244502140), received between Feb 11, 2025 and Sep 11, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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, 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Break

  Sheath was difficult to remove Then it separated into 2 pieces. Distal broken end of Sheath was removed via surgical cutdown.What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue? Doctor was patient pulling back Device/Procedure Outcome: Unable to Use Device - Attempted, Procedure Completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728087 ↗
• MalfunctionJun 8, 2026Unraveled Material

  PHYSICIAN WAS DOING AN AORTAGRAM WITH RUN OFF IN A PATIENT WITH PAST MEDICAL HISTORY OF SURGERY IN THE GROIN WE WERE WORKING IN. MD MADE TEAM AWARE IT WAS GOING TO BE A DIFFICULT GROIN TO WORK IN. CASE WAS GOING SMOOTHLY WITH A STENT DEPLOYED AND POST DILATED WITH A MUSTANG BALLOON. WHEN THE PHYSICIAN WENT TO REMOVE THE SHEATH OVER AN AMPLATZ WIRE, TO OUT IN A SHORT 6FR SHEATH FOR CLOSURE IT STARTED TO UNRAVEL OVER THE WIRE AND CONTINUED UNRAVELING INTO THE PATIENTS BODY. THE PROXIMAL PORTION OF THE SHEATH WAS CUT AND REMOVED OVER THE WIRE, WHERE A MUSTANG BALLOON WAS PUT OVER THE WIRE AND INFLATED AT THE END OF THE SHEATH TO SECURE IT TO BE REMOVED FROM THE BODY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: MUSTANG BALLOON INFLATION AT END OF SHEATH. AS REPORTED DEVICE CODES: 1163: DAMAGED/DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427163 ↗
• MalfunctionJun 3, 2026Fracture; Detachment of Device or Device Component

  "DURING THE PROCEDURE DR. (B)(6) OPENED AND PREPPED THE CATAPULT SHEATH ACCORDING TO THE IFU AND THEN INSERTED THE SHEATH INTO THE GROIN ACCESS. AS HE INSERTED THE SHEATH, HE FELT SOMETHING WAS OFF AND QUICKLY REMOVED THE SHEATH. AT THAT POINT, THE SHEATH WAS FULLY REMOVED FROM THE VESSEL, STILL INTACT, BUT IT WAS OBSERVED THAT THE SHEATH BRAIDING CAME APART AND WAS UNRAVELING AT THE HUB. THE SCRUB TECH QUICKLY ISOLATED THE SHEATH TO BE RETURNED FOR INVESTIGATION AND PROCEEDED ON WITH THE PROCEDURE USING A TERUMO DESTINATION SHEATH, WHICH WAS INSERTED SUCCESSFULLY INTO THE VESSEL". WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? NO TROUBLESHOOTING TOOK PLACE ONCE THE PHYSICIAN NOTICED THE SHEATH HUB UNRAVELING. WHAT IS THE NEXT COURSE OF ACTION? REMOVED THE SHEATH AND OPENED UP A DIFFERENT ONE, PROCEEDED ON WITH THE PROCEDURE. AS REPORTED DEVICE CODES: 1048: BREAK, 1307: DIFFICULT TO INSERT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374843 ↗
• MalfunctionApr 24, 2026Break; Fracture; Difficult to Remove; Detachment of Device or Device Component

  EVENT DESCRIPTION: THE SHEATH WAS PLACED IN LEFT GROIN AND WAS UP AND OVER TO THE RIGHT LOWER EXTREMITY. THE SURGEON SAID THE LEFT GROIN WAS VERY SCARRED. UPON COMPLETION OF THE INTERVENTION THE SURGEON WAS REMOVING THE SHEATH WHEN IT MET RESISTANCE DUE TO THE SCAR TISSUE. HE NOTICED IT STARTED TO UNRAVEL AND EVENTUALLY CAME APART. HE THEN ATTEMPTED TO SNARE THE FRACTURED PORTION BUT WAS UNSUCCESSFUL. HE CUT DOWN ON THE LEFT GROIN AND WAS ABLE TO SAFELY EXTRACT THE FRACTURED PORTION. THE PATIENT HAD NO COMPLICATIONS AND WAS DISCHARGED THE FOLLOWING DAY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ATTEMPTED SNARE. THEN SURGICAL CUT DOWN TO EXTRACT FRACTURED PORTION. WHAT IS THE NEXT COURSE OF ACTION?: SURGICAL EXTRACTION WAS SUCCESSFUL. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,UNABLE TO USE DEVICE - ATTEMPTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24980312 ↗
• MalfunctionMar 4, 2025Difficult to Remove; Difficult to Remove

  THE PROBLEM WAS DESCRIBED AS: "THE 6FRX45CM CATAPULT SHEATH WAS PLACED INTO THE ANTERIOR TIBIAL VEIN AT THE LEVEL OF THE ANKLE. IT REMAINED IN THE AT VEIN FOR THREE HOURS. AT WHICH TIME THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH. THE SHEATH WAS STUCK IN THE ANTERIOR TIBIAL VEIN AND REQUIRED A CUT DOWN TO REMOVE IT. THE PATIENT IS DOING WELL." WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? A CUT DOWN WAS PERFORMED TO REMOVE THE SHEATH. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: OTHER. PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: THE SHEATH WAS STUCK IN THE ANTERIOR TIBIAL VEIN AND REQUIRED A CUT DOWN TO REMOVE IT. 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? THE SHEATH WAS STUCK IN THE ANTERIOR TIBIAL VEIN AND REQUIRED A CUT DOWN TO REMOVE IT. MEDICAL OR SURGICAL INTERVENTIONS: THE SHEATH WAS STUCK IN THE ANTERIOR TIBIAL VEIN AND REQUIRED A CUT DOWN TO REMOVE IT. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: NO. PATIENT OUTCOME: FULLY RECOVERED. AS REPORTED DEVICE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517868 ↗
• MalfunctionFeb 11, 2025Stretched; Stretched

  THE PROBLEM WAS DESCRIBED AS: "SHEATH WAS REMOVED WITH DILATOR AND UNCOILED INSIDE PATIENT" WHAT IS THE NEXT COURSE OF ACTION?: TRIED TO SNARE SHEATH. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: BLEEDING, DISCOMFORT / PAIN, 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?: SHEATH FELL APART INSIDE PATIENT. MEDICAL OR SURGICAL INTERVENTIONS: OPEN PROCEDURE. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: YES. PATIENT DISCHARGED FROM HOSPITAL?: NO. PATIENT OUTCOME: UNKNOWN. DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,UNABLE TO USE DEVICE - ATTEMPTED PATIENT OUTCOME: F08: HOSPITALIZATION OR PROLONGED HOSPITALIZATION, F2301: ADDITIONAL DEVICE REQUIRED, F1901: ADDITIONAL SURGERY. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9128: HEMORRHAGE 9205: PAIN, 9069: DISCOMFORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21354348 ↗