Catapult Guide Sheath 7F, 45cm, straight, hydrophilic coatedRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04251244502201), received between May 10, 2024 and May 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Fracture; Fracture

  THE PROBLEM WAS DESCRIBED AS: "A PLANNED RIGHT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION WAS PERFORMED VIA A 7 FR X 45 CM SHEATH THAT WAS PLACED BY DR. (B)(6) IN THE RIGHT DORSALIS PEDIS ARTERY. AT THE CONCLUSION OF THE PROCEDURE, AN ATTEMPT WAS MADE BY DR. (B)(6) TO WITHDRAW THE SHEATH. THE SHEATH EXPERIENCED A FRACTURE WHICH MADE IT IMPOSSIBLE TO DIRECTLY REMOVE THE DEVICE. THE ENTRAPPED SHEATH WAS SUCCESSFULLY REMOVED WITH SURGICAL EXPOSURE AND DIRECT ARTERIAL REPAIR. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED THE FOLLOWING DAY." TYPE OF PROCEDURE: RIGHT LOWER EXTREMITY ANGIOGRAM. OPERATOR OF DEVICE: HEALTH PROFESSIONAL. TYPE OF EVENT: MALFUNCTION. DEVICE AVAILABLE FOR EVALUATION: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991666 ↗
• MalfunctionNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  7X45 CATAPULT SHEATH SHEARED OFF INSIDE PATIENT. ACCESS OBTAINED THROUGH LEFT COMMON FEMORAL ARTERY WITH PERCUTANEOUS NEEDLE AND ZIP WIRE. NEXT A 6 F SUPER SHEATH WAS ATTEMPTED TO BE ENTERED THROUGH THE ARTERIOTOMY SITE BUT DUE TO SEVERE SCARRING FROM A PREVIOUS FEMPOP SURGERY, IT HAD TO BE DOWNSIZED TO A 5 F SUPER SHEATH. FROM HERE THE SITE WAS DILATED UP USING A 6 F THEN 7 F SUPER SHEATH. AMPLATZ SUPER STIFF WIRE WAS PLACED UP AND OVER BIFURCATION FOR EXTRA SUPPORT AND THE 7X45 CATAPULT SHEATH WAS INSERTED. ATHERECTOMY AND ANGIOPLASTY WERE PERFORMED AND UPON REMOVING THE 7 F CATAPULT SHEATH SHEARED OFF INSIDE THE PATIENT. WIRE ACCESS WAS MAINTAINED AND A 5 MM CHARGER BALLOON WAS ADVANCED INTO PT JUST BEYOND THE END OF THE SHEATH. BALLOON WAS INFLATED AND THEN USED TO PULL SHEARED OFF PORTION OF SHEATH TOWARD THE ARTERIOTOMY SITE. A SMALL INCISION WAS MADE IN THE LEFT GROIN AREA AND HEMOSTATS WERE USED TO GRAB SHEATH AND REMOVE FROM THE BODY. 7 SUPER SHEATH WAS THEN INSERTED AND 7 F CELT DEVICE WAS USED FOR CLOSURE. OUTCOME OF PROCEDURE- PATIENT STABLE AT DISCHARGE DAMAGED PRODUCT DISCARDED BY STAFF REPLACEMENT ITEM REQUESTED." AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786495 ↗
• MalfunctionAug 6, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: "DURING CLOSURE DR WENT TO REMOVE SHEATH IT SPLIT INHALF." WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: WAS ABLE TO REMOVE WITHOUT COMPLICATIONS. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. TYPE OF PROCEDURE: ANGIO. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED, PROCEDURE COMPLETED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT AS REPORTED DEVICE CODES: 1048: BREAK . AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915154 ↗
• MalfunctionMay 10, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: THE MD DID HAVE A HARD TIME ADVANCING THE SHEATH DUE TO A VERY 'SCARRED GROIN.' THE ENTIRE SFA INTO THE COMMON FEMORAL WAS OCCLUDED WITH MULTIPLE PREVIOUS STENTS NOTED. HE STARTED AT THE DISTAL SFA AND BALLOONED WITH MULTIPLE SIZES. HE WAS ATTEMPTING TO PULL THE SHEATH BACK TO BALLOON THE COMMON FEMORAL. WHEN PULLING BACK, THE SHEATH SNAPPED, THUS BREAKING IT AND THE STAINLESS STEEL COILS WERE PULLED OUT AND EXPOSED. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NEW SHEATH WHAT IS THE NEXT COURSE OF ACTION?: NEW SHEATH PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT TYPE OF PROCEDURE: ARTERIAL INPUT FUNCTION (AIF) AS REPORTED DEVICE CODES: 1163: DAMAGED/DEFECTIVE, 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286901 ↗