DESTINATION RSC05Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00389701007847), received between Sep 26, 2017 and Jul 14, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT AN ANGIOGRAM WAS PERFORMED, AND THE PROCEDURE WAS FINISHED. THEY REMOVED THE SHEATH TO INSERT THE ANGIO-SEAL. UPON REMOVAL OF THE SHEATH, IT RIPPED. THEY WERE ABLE TO REMOVE THE ENTIRE DEVICE. THE PATIENT WAS NOT HARMED, AND THE PROCEDURE WAS SUCCESSFUL. NO BLOOD LOSS WAS REPORTED. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 25JUN2025: AN ANGIO-SEAL WAS USED IN THE CASE; HOWEVER, THERE WERE NO ISSUES WITH IT. THE DESTINATION WAS THE ONLY PROBLEM. THE PATIENT WAS STABLE. THE SHEATH WAS VISUALLY INSPECTED TO CONFIRM THAT IT WAS REMOVED FROM THE PATIENT ENTIRELY. THE PROCEDURAL SHEATH SIZE WAS A 6 FRENCH. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE VESSEL WAS NOT TORTUOUS AT THE LOCATION OF THE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494244 ↗
• MalfunctionJun 26, 2025Off-Label Use; Off-Label Use

  THE USER FACILITY REPORTED THAT THE PRODUCT EXPIRED ON (B)(6) AND WAS USED ON (B)(6). NO ADVERSE EVENTS WERE REPORTED. THE PROCEDURE PERFORMED WAS A FEMORAL INTERVENTION. THERE WAS NO BLOOD LOSS. REPORTED. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22339534 ↗
• MalfunctionApr 10, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION DEVICE 6/90 WAS USED IN A PATIENT UNDERGOING A CAROTID ARTERY EMBOLIZATION PROCEDURE. THE TRAINING PHYSICIAN NOTICED THAT THE VALVE OF THE DESTINATION SHEATH MALFUNCTIONED. THE VALVE WOULD NOT CLOSE COMPLETELY, HENCE THERE WAS BACK FLOW OF BLOOD. THEREFORE, THE DEVICE WAS DISCARDED, AND THE CASE WAS FINISHED WITHOUT USING ANY SHEATH. THE CASE WAS UNEVENTFUL, AND THE PROCEDURE OUTCOME WAS SATISFACTORY. NO ADVERSE EVENT RECORDED. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2024: THE PATIENT WAS IN STABLE CONDITION. THERE WAS MINIMAL BLOOD LOSS AS THEY COULD CONTROL THE LOSS IMMEDIATELY. THERE WAS NO OTHER PRODUCT USED WITH DESTINATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079463 ↗
• MalfunctionMay 11, 2021Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT IT WAS NOT POSSIBLE TO ADVANCE THE DESTINATION ON THE GUIDEWIRE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON 30APR2021. THE PROCEDURE BEING PERFORMED WAS A NEURO. THERE WAS NO DAMAGE REALLY VERY VISIBLE ON THE TIP OF THE DILATOR WHEN IT COULD NOT BE ADVANCED ON THE GUIDEWIRE, THEY ONLY NOTICED IT WHEN THEY WANTED TO ADVANCE IT ON THE GW. THEY CONTINUED THE PROCEDURE WITH A SECOND DS. A TERUMO GW WAS USED. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804878 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THEY OPENED A 6 FR DESTINATION SHEATH THE STOPCOCK WAS NOT SECURE IN THE PACKAGING AND FELL ON THE FLOOR. A NEW DESTINATION SHEATH HAD TO BE OPENED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 23APRIL2021: THE PATIENT WAS IN STABLE CONDITION; THE PRODUCT PACKAGING ISSUE DID NOT AFFECT THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SECOND DESTINATION. THE PROCEDURE PERFORMED WAS A HEART CATHETERIZATION. THIS OCCURRED BEFORE THE PATIENT WAS LOADED IN THE CATH LAB ROOM. THE STAFF WAS GETTING THE ROOM READY AND OPENED THE DESTINATION TO HAVE IT READY TO GO. THIS IS WHEN THE STOP CLOCK FELL OUT OF THE PACKAGING BECAUSE IT WAS NOT SECURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778018 ↗
• MalfunctionApr 29, 2021Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT A DURING A PERIPHERAL INTERVENTION CASE, TECH NOTED THAT THE 6F X 90CM DESTINATION DILATOR WOULD NOT FIT/ADVANCE INTO THE DESTINATION CATHETER. ANOTHER 6F X 90CM DESTINATION WAS USED SUCCESSFULLY INSTEAD. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A SUCCESS. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748242 ↗
• InjuryJan 13, 2021Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED ON 04FEB2021. THE VESSEL WAS BEING ACCESSED WITH THE DESTINATION SHEATH WAS THE LEFT BRACHIAL ARTERY. FLUOROSCOPY OF THE SHEATH REVEALED THAT THERE WAS SEPARATION OF THE WALL OF THE SHEATH AT THE PROXIMAL INSERTION SITE WHERE THERE WAS UNRAVELING OF THE BRAIDED PART. AFTER COMPLETION OF THE PROCEDURE THE CATHETER AND SHEATH BEGAN TO SHEAR OFF AND MADE PULLING THE CATHETER OUT IN THE CATHETERIZATION LAB UNSAFE. THE CATHETER WAS REMOVED IN ITS ENTIRETY WITHOUT ANY RESISTANCE. THE DESTINATION SHEATH WAS ADVANCED WITH NO RESISTANCE AND POSITIONED IN THE DISTAL AORTA. THE VESSEL THAT THE SHEATH GOT CAUGHT IN WAS THE LEFT BRACHIAL ARTERY.

  Patient problems: Insufficient Information

  MAUDE report 11158413 ↗
• MalfunctionNov 13, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION WAS USED DURING THE PROCEDURE. WHEN POWER INJECTING THROUGH THE SHEATH WITH A .035 GLIDEWIRE ADVANTAGE IN THE SHEATH AND WITHOUT THE WIRE, CONTRAST SPRAYED FROM THE VALVE ON BOTH INSTANCES. NO BLOOD LEAKED OTHERWISE. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 22OCT2020. THE PROCEDURE PERFORMED WAS A RIGHT LEG ANGIOGRAM UP AND OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835092 ↗
• MalfunctionSep 16, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE SHEATHS WERE KINKED INSIDE THE PACKAGE AND WERE UNUSABLE FOR THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 25AUG2020. THEY WERE BOTH FOUND KINKED WITHIN THE PACKAGE; HOWEVER, ONE WAS OPENED FOR INSPECTION. THEY USED AN UNDISCLOSED COMPETITORS' SHEATH TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10539925 ↗
• InjurySep 16, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE SHEATHS WERE KINKED INSIDE THE PACKAGE AND WERE UNUSABLE FOR THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 25AUG2020. THEY WERE BOTH FOUND KINKED WITHIN THE PACKAGE; HOWEVER, ONE WAS OPENED FOR INSPECTION. THEY USED AN UNDISCLOSED COMPETITORS' SHEATH TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10539914 ↗
• MalfunctionJul 24, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH WAS DAMAGED WITH A KINK WHILE STILL IN THE PACKAGE. THE PRODUCT WAS NOT REMOVED FROM THE PACKAGE SINCE THE KINK COULD BE OBSERVED WHILE STILL IN THE PACKAGE. ADDITIONAL INFORMATION WAS RECEIVED ON 07JULY2020: THIS WAS DISCOVERED IN STORAGE BEFORE THE PROCEDURE. THEY OPENED A SEPARATE SHEATH FOR THE CASE. THE PATIENT WAS STABLE, AND CASE COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10320689 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHEN THE INVOLVED DESTINATION WAS OPENED, THE DEVICE WAS KINKED. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 02JUL2020. IT WAS THE SHEATH THAT WAS KINKED. ADDITIONAL INFORMATION WAS RECEIVED ON 07JUL2020. ALL THREE DEVICES WERE CONFIRMED TO BE USED ON THE SAME PATIENT. THE PHYSICIAN FOUND A TERUMO SHEATH THAT WAS NOT KINKED TO USE DURING THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301312 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHEN THE INVOLVED DESTINATION WAS OPENED, THE DEVICE WAS KINKED. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 02JUL2020. IT WAS THE SHEATH THAT WAS KINKED. ADDITIONAL INFORMATION WAS RECEIVED ON 07JUL2020. ALL THREE DEVICES WERE CONFIRMED TO BE USED ON THE SAME PATIENT. THE PHYSICIAN FOUND A TERUMO SHEATH THAT WAS NOT KINKED TO USE DURING THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301286 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHEN THE INVOLVED DESTINATION WAS OPENED, THE DEVICE WAS KINKED. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 02JUL2020. IT WAS THE SHEATH THAT WAS KINKED. ADDITIONAL INFORMATION WAS RECEIVED ON 07JUL2020. ALL THREE DEVICES WERE CONFIRMED TO BE USED ON THE SAME PATIENT. THE PHYSICIAN FOUND A TERUMO SHEATH THAT WAS NOT KINKED TO USE DURING THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301264 ↗
• InjuryJun 10, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE DESTINATION GUIDING SHEATH DISLODGED DURING THE PROCEDURE. THE PHYSICIAN WAS ABLE TO SNARE THE BROKEN PORTION DURING THE PROCEDURE. THE PATIENT CONDITION WAS STABLE, AND THE PROCEDURE OUTCOME WAS POSITIVE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21MAY2020. THE PROCEDURE PERFORMED WAS A LEFT LOWER EXTREMITY ANGIOGRAM. TESTING WAS CONFIRMED THAT NO REMAINING PIECES WHERE LEFT BEHIND. THERE WAS NO EXTRA BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 10137279 ↗
• MalfunctionFeb 14, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2020 . RESISTANCE WAS FELT DURING INSERTION OR WITHDRAWAL OF SHEATH. THE DILATOR COULD NOT BE INSERTED INSIDE THE SHEATH. NO DAMAGE WAS NOTED BEFORE SHEATH INSERTION HOWEVER, THE WHEN THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER SHEATH THE DAMAGE WAS NOTED. A NEW 7 FR 90 CM DESTINATION SHEATH WAS USED AND THE DILATOR WAS INSERTED IN THE SHEATH. THE PHYSICIAN'S NOTE, COMMENTS AND OBSERVATIONS STATED THE FOLLOWING: "THE PATIENT'S ABDOMINAL AORTA WAS WIDELY PATENT WITH NO OBVIOUS FLOW LIMITING LESIONS. THE PATIENT'S RENAL ARTERIES BILATERALLY WERE WIDELY PATENT WITH NO FLOW LIMITING LESIONS. THE PATIENT DID HAVE SOME MILD STENOSIS OF THE RIGHT COMMON ILIAC ARTERY BUT DID NOT APPEAR TO BE FLOW LIMITING. LEFT COMMON ILIAC ARTERY IS WIDELY PATENT AND THE RIGHT WAS ENTIRELY NORMAL. LEFT CFA HAD A HIGH GRADE STENOSIS OF QUESTIONABLE SIGNIFICANCE, BILATERAL HYPOGASTRIC ARTERIES WERE PATENT. BILATERAL EXTERNAL ILIAC ARTERIES WERE PATENT, AND THE RIGHT WAS ENTIRELY NORMAL. LEFT CFA HAD A HIGH GRADE STENOSIS OF QUESTIONABLE SIGNIFICANCE. BILATERAL PROFUNDA FEMORIS WERE WIDELY PATENT WITH NO FLOW LIMITING LESIONS. BILATERAL SFAS WERE WIDELY PATEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714025 ↗
• InjuryFeb 6, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2020 : NORMAL FORCE WAS APPLIED TO GUIDE THE DESTINATION SHEATH THOUGH THE CALCIFIED VESSELS. THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WAS BEING TREATED. HEPARIN WAS USED AND THE ACT (ACTIVATED CLOTTING TIME) GOAL WAS ABOVE 250. THE TIP OF THE SHEATH WAS NOTICED TO BE BROKEN AFTER REMOVAL FOR SHEATH EXCHANGE. THE BROKEN TIP WAS STILL PARTIALLY ATTACHED TO THE SHEATH. PRIOR TO THE REMOVAL OF THE SHEATH, NO BALLOONS WERE CUT AND NO DCB'S (DRUG-COATED BALLOON) WERE USED TO TREAT THE CLI (CHRONIC CRITICAL LIMB ISCHEMIA). THE SEVERITY OF THE CALCIFICATION WAS MILD. BLOOD FLOW WAS BRISK. THERE WAS NO SCAR TISSUE. DISTAL EMBOLUS WAS ASPIRATED WITH THE ASPIRATION CATHETER. SHEATH WAS EXCHANGED FOR A SHORTER SHEATH, 6FR X 45 CM SHEATH.

  Patient problems: Embolus

  MAUDE report 9676351 ↗
• InjurySep 26, 2017Defective Device

  THE USER FACILITY REPORTED THAT BEFORE USE THEY SAW THAT THE FORM OF THE VALVE IS DEFECT. THE INNER PART OF THE DESTINATION COULD NOT BE FIXED IN THE OUTER PART. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6893236 ↗