Catapult Guide Sheath 6F, 45cm, straight, hydrophilic coatedRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04251244502096), received between Jan 18, 2024 and May 4, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 13, 2025Material Fragmentation; Material Fragmentation

  THE PROBLEM WAS DESCRIBED AS: "PLACED SHEATH, COMPLETED PROCEDURE, ATTEMPTED TO REMOVE SHEATH, IT WAS DIFFICULT, SHEATH VALVE CAP BROKE OFF, REMOVED SHEATH, CONTINUED TO CLOSURE" PATIENT PRESENT AT TIME OF EVENT? YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS AS REPORTED DEVICE CODES: 1346: DIFFICULT TO REMOVE, 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS TYPE OF PROCEDURE: LEG ANGIO . DEVICE/PROCEDURE OUTCOME: DEVICE OUT OF SERVICE - EXPLANTED OR REMOVED, UNABLE TO USE DEVICE - ATTEMPTED, PROCEDURE COMPLETED . PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372036 ↗
• MalfunctionOct 18, 2024Use of Device Problem; Use of Device Problem

  THE PROBLEM WAS DESCRIBED AS: "THE CATAPULT 6X45 STRAIGHT TIP SHEATH WAS INSTALLED SUCCESSFULLY. WIRES AND CATHETERS CROSSED WITHOUT AN ISSUE. SHOCKWAVE CATHETER WAS INSERTED AND USED IN ACCORDANCE WITH IFU. WHEN THE SHOCKWAVE CATHETER WAS AT EOL, THE BALLOON WAS DEFLATED WITH NEGATIVE PRESSURE. THE PHYSICIAN BEGAN TO WALK THE CATHETER OUT AND IT GOT CAUGHT UP AT THE DISTAL END OF SHEATH (AS IT WAS BEING RE-SHEATHED). WHEN IT WOULD NOT COME OUT EASILY, THE DOC USED SYRINGES AND INFLATION DEVICE TO PULL EXTREME NEGATIVE PRESSURE. THE DEVICE WOULD STILL NOT COME OUT SMOOTHLY. PHYSICIAN HAD TO APPLY EXTREME FORCES TO REMOVE DEFLATED BALLOON CATHETER THROUGH THE SHEATH. ONCE THE SHOCKWAVE BALLOON CATHETER WAS REMOVED, PHYSICIAN INSERTED A PENUMBRA CATHETER INTO SHEATH AND HAD SOME RESISTANCE MOVING IT THROUGH THE DISTAL END OF SHEATH, BUT IT DID GO. CASE WAS COMPLETED NORMALLY. WHEN THE CASE WAS OVER AND THE SHEATH WAS REMOVED, THERE WAS PHYSICAL DEFORMATION AT THE DISTAL END OF THE SHEATH. THE DILATOR WAS THEN PLACED IN THE SHEATH AND THE SHEATH WAS PLACED IN A BIO BAG TO BE RETURNED WITH THE COMPLAINT. NOTE: THEY PHYSICIAN NOTED THAT THIS HAPPENED IN A CASE YESTERDAY BUT HE DID NOT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478835 ↗
• MalfunctionJun 4, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: "PHYSICIAN PULLED SHEATH BACK UP AND OVER A VERY STEEP, TORTUOUS, ANGULATED, AND CALCIFIED BIFURCATION. THE SHEATH SEPARATED THEN SEPARATED." PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. TYPE OF PROCEDURE: ANGIOGRAM SUPERFICIAL. DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,DIFFERENT DEVICE USED (SAME MODEL)PATIENT OUTCOME: F26: NO HEALTH. CONSEQUENCES OR IMPACT. AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. ON 12.06.2024 THE CUSTOMER PROVIDED BELOW ADDITIONAL INFORMATION: 1. IN WHICH STEP OF THE PROCEDURE EVENT OCCURRED (ADVANCING THE SHEATH / RELOCATION / REMOVAL)? REMOVAL. 2. PLEASE DESCRIBE THE PATIENT ANATOMY DURING OPERATION. STEEL BIFURCATION, HEAVILY CALCIFIED. 3. PLEASE DESCRIBE THE APPLIED PROCEDURE IN DETAIL INCLUDING ALL OTHER USED DEVICES (PRODUCT NAME, PRODUCT CODE) AND INFUSION LIQUIDS (PRODUCT NAME, PRODUCT CODE). UNKNOWN. 4. WAS THERE INCREASED RESISTANCE FELT DURING THE PROCEDURE, E.G. DUE TO CALCIFICATION OR SCAR TISSUE? UNKNOWN. 5. WHAT WAS THE PHYSICIAN EXPERIENCE LEVEL ON THIS TYPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456704 ↗
• MalfunctionJun 4, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: "WHILE REMOVING A PERIPHERAL BALLOON THE HUB CAME DISCONNECTED." PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. TYPE OF PROCEDURE: PERIPHERAL INTERVENTION. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,DIFFERENT DEVICE USED (SAME MODEL),PROCEDURE COMPLETED. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. 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 19456632 ↗
• MalfunctionMay 28, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: "DR. GOT ACCESS IN LEFT GROIN W CATAPULT. PERFORMED ATHERECTOMY IN LEFT LEG. WHEN EXCHANGING CATAPULT FOR SHORT SHEATH, IT CAME APART IN PATIENTS BODY. VASCULAR SURGERY HAD TO PERFORM CUT DOWN ON PATIENT TO REMOVE THE PIECES" PATIENT OUTCOME: F1901: ADDITIONAL SURGERY PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: SURGERY 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 CAME APART IN THE PATIENT MEDICAL OR SURGICAL INTERVENTIONS: VASCULAR CUTDOWN TO REMOVE SHEATH PIECES PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: YES PATIENT DISCHARGED FROM HOSPITAL?: NO PATIENT OUTCOME: EXPECTED TO FULLY RECOVER AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT TYPE OF PROCEDURE: PERIPHERAL ANGIOGRAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403158 ↗
• MalfunctionMar 20, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: "CASE WAS COMING TO THE END AND AS THE PHYSICIAN WAS PULLING THE SHEATH OUT THE SHEATH UNRAVELED INSIDE THE PATIENT." PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, ORIGINAL DEVICE USED TYPE OF PROCEDURE: ANGIOGRAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941405 ↗
• MalfunctionMar 1, 2024Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  THE CUSTOMER REPORTED AS FOLLOWS: CATAPULT SHEATH HAD A HARD TIME ENTERING THE 24F IMPELLA SHEATH. DEVICE/PROCEDURE OUTCOME: PROCEDURE - NO INFORMATION. AS REPORTED DEVICE CODES: 1307: DIFFICULT TO INSERT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. PATIENT OUTCOME: F24: INSUFFICIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18814880 ↗
• MalfunctionFeb 8, 2024Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  THE CUSTOMER REPORTED AS FOLLOWS: UNABLE TO USE DEVICE - ATTEMPTED "AFTER DEPLOYMENT OF AN EXPRESS LD STENT IN THE LEFT ILIAC ARTERY, THE PHYSICIAN DID ONE LAST ANGIOGRAM TO VISUAL THE STENT. ON REMOVAL OF THE STENT, THE GREEN HUB ON THE CATAPULT SHEATH POPPED OFF." OVERALL THE SHEATH WAS REPLACED WITH A NEW SHORT 11CM 6F SHEATH.PROCEDURE COMPLETED. 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. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668869 ↗
• MalfunctionJan 30, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTED AS FOLLOWS: UNABLE TO USE DEVICE: ATTEMPTED. THE PROBLEM WAS INDICATED AS "THE SHEATH REMOVAL WAS ATTEMPTED AND THE SHEATH BROKE INSIDE THE BODY INTO SEVERAL PIECES. THE PATIENT IS FULLY RECOVERED.DIFFICULT BIFURCATION MEDICAL OR SURGICAL INTERVENTIONS. TYPE OF PROCEDURE: ANGIOGRAM. AS REPORTED DEVICE CODES: 1048: BREAK. AS REPORTED PATIENT CODES: 9124: HEMATOMA.. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT OUTCOME: F11: MINOR INJURY, ILLNESS, IMPAIRMENT. PATIENT COMPLICATIONS: BLEEDING, HEMATOMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604604 ↗
• MalfunctionJan 18, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED BY THE PHYSICIAN AS FOLLOWS: "EVENT DESCRIPTION: IT APPEARS, THAT HUB FRACTURED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532806 ↗