Catapult Guide SheathRecalls & reported problems across all models

We found 8 models of Catapult Guide Sheath by Contract Medical International GmbH in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2024 and Sep 11, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Catapult Guide Sheath problems

Catapult Guide Sheath models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Catapult Guide Sheath 6F, 45cm, straight, hydrophilic coated

  Introducer, Catheter
  15 reports
• Catapult Guide Sheath 6F, 60cm, straight, hydrophilic coated

  Introducer, Catheter
  6 reports
• Catapult Guide Sheath 7F, 45cm, straight, hydrophilic coated

  Introducer, Catheter
  4 reports
• Catapult Guide Sheath 8F, 60cm, straight, hydrophilic coated

  Introducer, Catheter
  2 reports
• Catapult Guide Sheath 5F, 60cm, straight, hydrophilic coated

  Introducer, Catheter
  1 report
• Catapult Guide Sheath 5F, 90cm, straight, hydrophilic coated

  Introducer, Catheter
  1 report
• Catapult Guide Sheath 6F, 45cm, Multipurpose, hydrophilic coated

  Introducer, Catheter
  1 report
• Catapult Guide Sheath 8F, 90cm, straight, hydrophilic coated

  Introducer, Catheter
  1 report

Recent Catapult Guide Sheath adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  EVENT DESCRIPTION: HUB OF SHEATH BROKE OFF DURING INSERTION RESULTING IN NEEDING TO OPEN A NEW ONE. TYPE OF PROCEDURE: NO VALUE FOUND. PATIENT COMPLICATIONS: NO. PATIENT COMPLICATIONS PATIENT OUTCOME: UNKNOWN. AS REPORTED DEVICE CODES: 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 25066228 ↗
• 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 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  THE FOLLOWING DETAILS ARE PROVIDED BY THE CUSTOMER: DESCRIPTION: WHEN REMOVING THE SHEATH, THE HUB OF IT PULLED APART. WHAT TROUBLESHOOTING STEPS TOOK PLACE: PULLED SHEATH ALL THE WAY OUT. TYPE OF PROCEDURE: RIGHT LEG ANGIOGRAM/INTERVENTION. DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE - ATTEMPTED. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. THE CUSTOMER HAS PROVIDED PICTURE OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428169 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  THE PROBLEM IS DESCRIBED AS FOLLOWED: "ASKED, UNAVAILABLE" DESCRIPTION: NULL" - AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. TYPE OF PROCEDURE: PERIPHERAL. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. THE CUSTOMER HAS PROVIDED ADDITIONAL PICTURES OF THE COMPLAINT DEVICE. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON REQUEST ON 21.01.2026: "IF FAILURE MODE IS 'OTHER,' DETAILS: SHEATH SEPARATED AT THE HUB. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO". THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON REQUEST ON 18.02.2026: "WAS THE HYDROPHILIC COATING ACTIVATED? YES WAS THE DILATOR USED? YES. WERE THERE ANY KINKS OR BENDS IN THE SHEATH? NO. IN WHICH BODY PART DID THE INCIDENT HAPPEN? RIGHT GROIN. WHAT WAS THE PHYSICIAN'S LEVEL OF EXPERIENCE IN THE SAME TYPE OF OPERATION? OVER 40 YEARS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219854 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  HERAEUS MEDEVIO DRESDEN HAD RECEIVED A CUSTOMER COMPLAINT NOTIFICATION FROM CUSTOMER. THE ONLY INFORMATION PROVIDED IN THE FIELD "EVENT DESCRIPTION" IS THE FOLLOWING: "THIS RECORD WAS AUTO SUBMITTED BY THE ECN ON BEHALF OF THE USER. INFORMATION MAY BE INCOMPLETE. ECN EVENT DESCRIPTION: NULL" - AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. TYPE OF PROCEDURE: ANGIOGRAPHY. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. DEVICE/PROCEDURE OUTCOME: PROCEDURE CANCELLED/RESCHEDULED, UNABLE TO USE DEVICE - ATTEMPTED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: FULLY RECOVERED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. ADDITIONAL INFORMATION PROVIDED BY DISTRIBUTOR ON 01/21/2026: "DISTRIBUTOR HAS PROVIDED ADDITIONAL IMAGES FOR THIS COMPLAINT. THE IMAGES SUGGEST THAT THE SHEATH WAS DETACHED FROM THE VALVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219774 ↗
• MalfunctionNov 26, 2025Break; Difficult to Insert; Difficult to Remove; Break; Difficult to Insert; Difficult to Remove

  THE PROBLEM IS DESCRIBED AS FOLLOWED: SHEATH HAD SOME TROUBLE TRACKING UPON INSERTION, AND WHEN TRYING TO REMOVE POSTTREATMENT IT SNAPPED IN HALF. UNRAVELING THE BRAIDED CORE INSIDE. PHYSICIAN WAS ABLE TO REMOVE COMPLETELY. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? : HEMOSTAT TO GRAB PORTION STILL INSERTED AND WAS ABLE TO REMOVE. WHAT IS THE NEXT COURSE OF ACTION? REPLACEMENT PATIENT PRESENT AT TIME OF EVENT? YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS AS REPORTED DEVICE CODES:1307: DIFFICULT TO INSERT, 1048: BREAK AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS TYPE OF PROCEDURE: ANGIOGRAM DEVICE/PROCEDURE OUTCOME: ORIGINAL DEVICE USED, PROCEDURE COMPLETED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. ADDITIONAL INFORMATION RECEIVED ON 11/20/2025 FROM THE CUSTOMER: Q1.ARE THERE ADDITIONAL DETAILS THAT CAN HELP THE INVESTIGATION? ANSWER FOR Q1: SHEATH SNAPPED IN HALF UPON REMOVAL WHEN COMING OVER THE BIFURCATION. PHYSICIAN MENTIONED IT WAS TIGHT UPON PUTTING IT IN. Q2.PLEASE MARK THE FAILURE AREA AND FAILURE TYPE FOR THE FAILURE AREA (E.G. FOR DEFORMED TIP 1-C, FOR VALVE CAP DETACHMENT CAUSING LEAKAGE 8-D,I) FAILURE TYPE(S)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655116 ↗
• 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 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  THE PROBLEM WAS DESCRIBED AS: "CATAPULT SHEATH FELL APART UPON INSERTION. SHEATH WAS REMOVED AN ALTERNATE SHEATH WAS USED. PATIENT IS DOING FINE AND CUSTOMER IS NOT UPSET." WHAT IS THE NEXT COURSE OF ACTION? COMPLAINT AND REPAIR OF THIS BATCH AND OTHERS THAT ARE LIKE IT PATIENT PRESENT AT TIME OF EVENT? YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS TYPE OF PROCEDURE: PERIPHERAL INTERVENTION AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE - ATTEMPTED, DIFFERENT DEVICE USED (DIFFERENT MODEL) PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393159 ↗
• 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 ↗
• MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PROBLEM WAS DESCRIBED AS: "THE HUB ON THE 8X60 CATAPULT COMES OFF DURING PROCEDURE CAUSING LEAKING, THIS HAPPENED ON TWO IN A ROW". AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,PROCEDURE - NO INFORMATION AVAILABLE. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT RETURNED. PRODUCT EXPECTED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717977 ↗
• MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PROBLEM WAS DESCRIBED AS: "THE HUB ON THE 8X60 CATAPULT COMES OFF DURING PROCEDURE CAUSING LEAKING, THIS HAPPENED ON TWO IN A ROW". AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,PROCEDURE - NO INFORMATION AVAILABLE PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. RETURNED PRODUCT EXPECTED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717836 ↗
• 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 ↗

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• Biotronik Fortress Introducer Sheath System12 models · 24 reports · 1 recall