DESTINATION 54-64501Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00389701008837), received between Feb 26, 2018 and Dec 27, 2025 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2025Material Separation; Material Separation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHEN THE PHYSICIAN TRIED TO REMOVE THE SHEATH, IT RIPPED. THEN THEY CUT THE SIDEARM PART OFF AND TRIED TO SLIDE A SMALLER DILATOR DOWN TO THE TIP OF THE SHEATH TO GET IT OUT. IT DID NOT WORK, AND THE PATIENT HAD TO GO TO THE HOSPITAL TO HAVE THE SHEATH REMOVED. ADDITIONAL INFORMATION WAS RECEIVED ON 09DEC2025: THE PROCEDURE FOR THE PATIENT AT THE TIME THE REPORTED ISSUE OCCURRED WAS A LEFT ANGIO. IT APPEARED THAT THERE MAY HAVE BEEN CALCIFICATION/TORTUOUS ANATOMY AT THE TIME THE DESTINATION DEVICE RIPPED AT THE TIP AS DESCRIBED WHEN TRYING TO REMOVE THE TIP OF THE SHEATH. THE PATIENT DID NOT EXPERIENCE SPASM AT THE TIME THE SHEATH RIPPED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND HAD A VASCULAR CUT DOWN. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901623 ↗
• InjuryMar 12, 2025Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PATIENT DEVELOPED A LARGE HEMATOMA IN HIS RIGHT GROIN SHORTLY AFTER PLACING A 6F X 45 DESTINATION IN THE LEFT GROIN. THE FEMORAL ARTERY WAS FIRST ACCESSED USING ULTRASOUND AND MICRO PUNCTURE. A 6F SHEATH WAS PLACED, AND DIAGNOSTIC IMAGES DETERMINED AN INTERVENTION WAS NEEDED. THE SHORT SHEATH WAS EXCHANGED FOR A 6F DESTINATION. SOON AFTER, THE VASCULAR SURGEON RECOGNIZED A SIGNIFICANT HEMATOMA. A CONTRAST IMAGE WAS USED TO CONFIRM THE BLEED. IT WAS DIFFICULT TO DETERMINE IF IT WAS COMING FROM THE ACCESS SITE OR A NEARBY SIDE BRANCH. AFTER HOLDING MANUAL PRESSURE AND REDUCING THE HEMATOMA, THE VASCULAR SURGEON TRIED TO PROCEED; HOWEVER, THE HEMATOMA GREW, AND HE DECIDED TO ABORT THE PROCEDURE. UPON REMOVING THE DESTINATION, THE TECHNICIAN NOTICED A SLIGHT DEFORMITY AT THE DISTAL TIP OF THE SHEATH. IT IS UNDETERMINED IF IT WAS LIKE THIS UPON ENTERING THE BODY. IF SO, IT WOULD NOT HAVE BEEN A SMOOTH TRANSITION FROM THE DILATOR TO THE SHEATH AND COULD HAVE CONTRIBUTED. MANUAL PRESSURE WAS ADMINISTERED, AND HEMOSTASIS WAS ACHIEVED. THE REPORTED EVENT RESULTED IN PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. IT WAS INCONCLUSIVE AS TO

  Patient problems: Hematoma

  MAUDE report 21580539 ↗
• MalfunctionDec 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED THAT UPON OPENING THE DESTINATION SHEATH, THE TECHNICIAN ATTEMPTED TO TIGHTEN THE VALVE, BUT IT WOULDN'T STAY TIGHT AND SEEMED TO UNSCREW COUNTERCLOCKWISE. THE TECHNICIAN APPLIED DERMABOND TO SECURE THE CAP. THE PROCEDURE PERFORMED WAS AN ANGIOGRAPHY WITH NO ESTIMATED BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 15 NOV 2024: THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925230 ↗
• MalfunctionDec 2, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE DILATOR WOULD NOT GO THROUGH THE SHEATH. THE PROCEDURE PERFORMED WAS AN ANGIOGRAM. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT UNDERWENT ROUTINE PRE-SURGERY TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820037 ↗
• MalfunctionJan 13, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH WAS INSERTED INTO THE PATIENT; THEY WERE UNABLE TO ADVANCE INTRODUCER INTO THE SHEATH. BOTH THE SHEATH AND INTRODUCER WERE PREPPED. THEY REMOVED IT WITHOUT INCIDENT AND USED ANOTHER ONE OF THE SAME PRODUCT WITHOUT ANY INCIDENT. IT WAS REPORTED THAT THE PATIENT HAD NO KNOWN ISSUE DUE TO THE ISSUE AND THE CASE WAS COMPLETED FINE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 23DEC2020. THE PROCEDURE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) FOR PERIPHERAL ARTERY DISEASE (PAD) CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159975 ↗
• MalfunctionDec 28, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT DRING UP AND OVER CASE TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA), THE DOCTOR HAD TROUBLE ADVANCING THE DESTINATION DEVICE PAST ACCESS SITE. HE REMOVED THE SHEATH AND NOTICED ACCORDION/FISH MOUTHING AT THE DILATOR/SHEATH TRANSITION. THE SHEATH WAS REMOVED, AND A NEW DESTINATION WAS ADVANCED WITH NO ISSUES. THE CASE CONTINUED SUCCESSFULLY, AND THE PATIENT WAS DOING WELL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077753 ↗
• MalfunctionNov 19, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 15DEC2020. THE SHEATH WAS COMPROMISED DUE TO IT BREAKING APART..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10870900 ↗
• MalfunctionSep 9, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE WAS DISCARDED. CUSTOMER STATED THAT THE DOCTOR WAS DOING A PERIPHERAL PROCEDURE AND THE DILATOR WENT INTO THE DESTINATION BUT AT THE DISTAL END OF THE SHEATH IT BUCKLED, AND THEY COULD NOT GET IT TO GO DOWN THE VESSEL. THEY TRIED ANOTHER ONE AND THE SAME THING HAPPENED. THEY REMOVED THE DESTINATIONS AND PUT IN A COOK FLEXOR CHECK FLO INTRODUCER AND HAD NO PROBLEM ADVANCING OVER THE WIRE DOWN THE VESSEL. THE BLOOD LOSS WAS LESS THAN 2500 CCS. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS A SUCCESS AND THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 21AUG2020: IT WAS AN UP AND OVER, WHEN THEY HAD THE DIFFICULTY DESCRIBED. THERE WAS NO TORTUOSITY REPORTED. PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10511217 ↗
• InjurySep 9, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE WAS DISCARDED. CUSTOMER STATED THAT THE DOCTOR WAS DOING A PERIPHERAL PROCEDURE AND THE DILATOR WENT INTO THE DESTINATION BUT AT THE DISTAL END OF THE SHEATH IT BUCKLED, AND THEY COULD NOT GET IT TO GO DOWN THE VESSEL. THEY TRIED ANOTHER ONE AND THE SAME THING HAPPENED. THEY REMOVED THE DESTINATIONS AND PUT IN A COOK FLEXOR CHECK FLO INTRODUCER AND HAD NO PROBLEM ADVANCING OVER THE WIRE DOWN THE VESSEL. THE BLOOD LOSS WAS LESS THAN 2500 CCS. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS A SUCCESS AND THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 21AUG2020: IT WAS AN UP AND OVER, WHEN THEY HAD THE DIFFICULTY DESCRIBED. THERE WAS NO TORTUOSITY REPORTED. PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10511135 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE WAS USED IN A PERIPHERAL VASCULAR PROCEDURE. THE SHEATH PERFORMED CORRECTLY DURING THE PROCEDURE. WHILE REMOVING THE SHEATH, THE HUB BECAME DISCONNECTED FROM THE SHAFT OF THE SHEATH. THERE WAS NO REPORTED BLOOD LOSS AND THERE WAS NO HARM TO THE PATIENT FROM THIS EVENT. THE PATIENT'S CONDITION WAS STABLE, AND THE PROCEDURE WAS A SUCCESS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 10JUN2020. THERE WERE NO PARTICLES REPORTED. THE BREAKING OF THE SHEATH SEEMED TO HAVE HAPPENED DURING REMOVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205660 ↗
• MalfunctionJun 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 04JUN2020. THE PROCEDURE PERFORMED WAS A LEG CASE. THE SHEATH CATHETER HUB WAS NOT ATTACHED, AND THE HUB FELL ON THE FLOOR. THE PATIENT WAS FINE AND NOT AFFECTED BY THE EVENT. THERE WAS NO DAMAGE NOTICED TO THE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2020. THE VALVE ASSEMBLY WAS SEPARATED FROM THE SHEATH HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10149219 ↗
• MalfunctionMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DESTINATION HUB WAS NOT CONNECTED TO THE SHEATH. THE HUB FELL ON THE FLOOR WHEN THE STERILE PACKAGE WAS OPENED. A NEW SHEATH WAS OPENED. ADDITIONAL INFORMATION WAS RECEIVED ON 27APR2020. THE ISSUE OCCURRED DURING PREPPING, WITHOUT THE PATIENT PRESENT. SINE THE HUB WAS NOT ATTACHED, IT FELL ON THE FLOOR. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 05MAY2020. THE REPORTED EVENT WAS DISCOVERED UPON OPENING THE PACKAGE. THE PROCEDURE BEING PERFORMED WAS AN ANGIOGRAM OF THE LOWER EXTREMITIES. THE PATIENT'S CONDITION WAS STABLE. ANOTHER SHEATH WAS OPENED, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 06MAY2020. A NEW TERUMO SHEATH WAS OPENED, AND THE CASE WAS CONTINUED WITH SUCCESSFUL TURNOUTS. THE PATIENT WAS PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061822 ↗
• MalfunctionMay 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DESTINATION HUB WAS NOT CONNECTED TO THE SHEATH. THE HUB FELL ON THE FLOOR WHEN THE STERILE PACKAGE WAS OPENED. A NEW SHEATH WAS OPENED. ADDITIONAL INFORMATION WAS RECEIVED ON 27APR2020. THE ISSUE OCCURRED DURING PREPPING, WITHOUT THE PATIENT PRESENT. SINE THE HUB WAS NOT ATTACHED, IT FELL ON THE FLOOR. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Patient Involvement

  MAUDE report 10021057 ↗
• MalfunctionDec 17, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH WAS USED IN THE LEFT GROIN FOR ACCESS DURING A VASCULAR INTERVENTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE FIRST SHEATH USED WAS A 6FR PRECISION SHEATH IN THE LEFT COMMON FEMORAL ARTERY. THE SHEATH WAS THEN EXCHANGED FOR THE DESTINATION SHEATH OVER A GLIDEWIRE ADVANTAGE. THE PHYSICIAN MET RESISTANCE AT THE INSERTION SITE. THE SHEATH BECAME FLARED FROM THE DILATOR AND WOULD NOT TRACK OVER THE WIRE INTO THE ARTERY. THE SHEATH WAS THEN EXCHANGED FOR ANOTHER DESTINATION WHICH ADVANCED EASILY INTO THE VESSEL. THERE WAS NO BLOOD LOSS OR PATIENT INJURY DUE TO THIS EVENT. THE PATIENT HAS PREVIOUSLY HAD MULTIPLE PROCEDURES IN THIS SAME ACCESS SITE. THE PATIENT WAS STABLE AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482334 ↗
• InjuryMar 20, 2018Break; Break

  THE USER FACILITY REPORTED THAT AFTER THE DESTINATION WAS INSERTED AND TRACKED UP AND OVER, THE DOCTOR AND TECH NOTICED THAT THE MARKER WAS NOT ON THE END OF THE SHEATH. IT WAS ACTUALLY BELOW THE ACCESS SITE ON THE PUNCTURE SIDE. THE TIP OF THE SHEATH WITH THE MARKER BAND HAD COME OFF AND WAS SITTING IN THE PROFUNDA. THEY TRIED TO SNARE IT BUT WAS UNSUCCESSFUL AS THE TIP OF SHEATH AND MARKER ACTUALLY SEPARATED FROM EACH OTHER. BOTH PIECES ACTUALLY FLOATED DEEP INTO AN ACCESSORY VESSEL OFF THE PROFUNDA AND THE DOCTOR DECIDED TO LEAVE IT THERE AS HE FELT THAT WAS THE SAFEST OPTION. IT WAS REPORTED THAT AFTER THIS, THEY WENT BACK IN WITH ANOTHER DESTINATION AND TREATED THE PATIENT SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE FINE AND STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7351861 ↗
• MalfunctionFeb 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY MEDWATCH 5075055 WAS RECEIVED BY THE FDA AND WAS RECEIVED BY TERUMO ON FEBRUARY 26, 2018 AND REPORTED THE FOLLOWING. "DURING PERIPHERAL INTERVENTION PROCEDURE, THE DETACHABLE VALVE FROM TERUMO DESTINATION SHEATH CAME APART FROM THE SHEATH. THE PATIENT LOST APPROX. 50 TO 100CC OF BLOOD LOSS BEFORE THE PROBLEM WAS IDENTIFIED AND CORRECTED. THE DETACHABLE VALVE IS TWISTED ON AND TIGHTENED BEFORE THE PROCEDURE BUT FREQUENTLY THE VALVE WILL NOT STAY SECURE AND SPONTANEOUSLY COMES OFF DURING PROLONGED PROCEDURES. THIS HAS HAPPENED SEVERAL TIMES IN THE PAST AND IT MAY RESULT IN A SIGNIFICANT AMOUNT OF BLOOD LOSS AND POTENTIALLY LIFE THREATENING SITUATIONS. DUE TO THE CLINICAL SIGNIFICANCE OF THIS ISSUE, WE RESPECTFULLY REQUEST THAT THE FDA INVESTIGATE THE PROBLEM."

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7296416 ↗