R2P Destination Slender GS-R6ST1C95WRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00389701012384), received between Oct 5, 2020 and Aug 25, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2024Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT THE PATIENT WAS HAVING A LOWER EXTREMITY ANGIOGRAM VIA THE LEFT RADIAL ARTERY. AT THE END OF THE PROCEDURE THE TR BAND WAS PLACED. WHILE WITHDRAWING THE R2P DESTINATION SLENDER, THE SHEATH STARTED TO UNCOIL AND BECAME LODGED IN PATIENT'S RADIAL ARTERY. THE PATIENT NEEDED TO HAVE AN EMERGENCY CUTDOWN TO REMOVE SHEATH. THE DILATOR WAS IN PLACE FOR REMOVAL AND THE WIRE WAS USED TO REMOVE SHEATH AT THE END OF PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 09JUL2024: THE PATIENT WAS DOING WELL; SHE WENT HOME LATER FRIDAY EVENING ON 26JUL2024. ADDITIONAL INFORMATION WAS RECEIVED ON 09AUG2024: THE PRE-PROCEDURAL CONDITION OF THE PATIENT WAS HISTORY OF PERIPHERAL ARTERY DISEASE (PAD) WITH KNOWN BYPASS. INITIALLY THEY THOUGHT IT WAS SPASMS, HOWEVER AFTER BEING COMPLETELY ANESTHETIZED THAT DID NOT HELP. THEY HAD TO EXTEND THE CUT DOWN INCISION AND DISSECT THE RADIAL ARTERY TO ABOUT 5-6CM PROXIMAL TO THE ACCESS POINT IN ORDER TO RELEASE IT FROM WHERE IT WAS STUCK OR HOOKED ON THE ARTERY. THE PATIENT WAS DOING WELL AND WENT HOME THAT EVENING AFTER A CUT DOWN AND SHEATH REMOVAL. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. A 4MM BALLOON AT THE BELOW KNEE (BK)

  Patient problems: Vascular Dissection

  MAUDE report 20061206 ↗
• MalfunctionJul 2, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DURING A RADIAL PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS A 6FR CATHETER THROUGH THE DESTINATION SLENDER PRODUCT. THE PROCEDURE WAS DIAGNOSTIC ONLY, THE CATHETER DID NOT PERFORM AS EXPECTED. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 15 JUN 2023: THEY WERE NOT ABLE TO GET THE 6FR CATH (PENUMBRA NEURO SHEATH) TO PASS THROUGH THE GUIDING SHEATH SLENDER. THEY REMOVED THE CATHETER, AND A 5FR SHEATH WAS PASSED UP INTO THE HEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244602 ↗
• InjuryJun 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 07 JUN 2023: PATIENT DID NOT HAVE PARTICULARLY TORTUOUS ANATOMY. THERE IS NO DIRECT ALLEGATION AGAINST THE DEVICE FROM THE CLINICIAN, THAT IT CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS CONFIRMED THAT THE SPASM OCCURRED DURING THE REMOVAL OF THE SHEATH. TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT MW# 5118842. THE EVENT DESCRIPTION STATED THAT THE PATIENT HAD AN OUTPATIENT ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE AND AFTER PLACEMENT OF STENTS, THE WIRE AND SHEATH WERE DIFFICULT TO PULL. MEDICATIONS WERE GIVEN TO RELAX THE VESSELS. THE SHEATH SEPARATED AND A PORTION REMAINED REQUIRING TRANSFER TO OPERATING ROOM FOR REMOVAL.

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 17244084 ↗
• MalfunctionMay 30, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT DURING A SPLENIC ARTERY ANEURYSM, THE PHYSICIAN WAS TRYING TO REMOVE AN UNDEPLOYED .018" VIA BAHN AND FELT RESISTANCE, AND THE PATIENT EXPERIENCED PAIN. HE APPLIED NITRO PASTE AND CAREFULLY REMOVED THE ENTIRE SYSTEM (SHEATH, VIA BAHN AND .018" WIRE). THE SHEATH WAS VISIBLY KINKED. HEMOSTASIS WAS ACHIEVED WITH THE TR BAND. THERE WAS NO SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS STABLE. THE TREATMENT OF SPLENIC ARTERY ANEURYSM PROCEDURE OUTCOME WAS UNSUCCESSFUL, HOWEVER WAS NOT RELATED TO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14541322 ↗
• MalfunctionMay 27, 2022Break; Activation, Positioning or Separation Problem; Material Deformation; Break; Activation, Positioning or Separation Problem; Material Deformation

  THE USER FACILITY REPORTED THAT THE R2P DEVICE INVOLVED WAS KINKED AND BROKEN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: AFTER THE DESTINATION SLENDER WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE SHEATH WAS KINKED AND BROKEN. THE DEVICE EITHER BROKE DURING PROCEDURE OR DURING REMOVAL. IT WAS NOTED THAT THE SHEATH WAS PULLED OUT OF PATIENT, BUT THERE WERE NO ISSUES REMOVING THE SHEATH. ONCE REMOVED FROM THE PATIENT, THERE WERE NO ISSUES INSIDE THE BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO BLOOD LOSS. UNCERTAIN IT IS RELATED TO THE BREAK, THE LAB NOTED THERE WAS A STEEP ILIAC BIFURCATION. THERE WERE NO DEVICES OR OTHER PRODUCTS USED WITH THE ABOVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521085 ↗
• InjuryApr 15, 2021Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 18MAY2021. THE DILATOR WAS IN PLACE WHEN THE SHEATH WAS INSERTED AND WAS IN PLACE WHEN THE PHYSICIAN WAS ATTEMPTING TO REACH THE ACCESS SITE. THE PHYSICIAN USED A 5/6 GLIDESHEATH SLENDER TO ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676393 ↗
• MalfunctionJan 20, 2021Material Deformation; Material Deformation

  THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205069 ↗
• MalfunctionOct 7, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORT THAT THE DOCTOR WAS UNABLE TO NAVIGATE THE R2P SLENDER GUIDING SHEATH FROM THE RIGHT SUBCLAVIAN TO THE RIGHT COMMON CAROTID ARTERY (RCCA). THEY THEN CONVERTED TO FEMORAL ACCESS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 16SEPT2020. THE PROCEDURE BEING PERFORMED WAS A STROKE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10645128 ↗
• MalfunctionOct 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR FELT RESISTANCE AT THE RIGHT COMMON CAROTID ARTERY (RCCA) AND SUBCLAVIAN JUNCTION WHILE USING AN R2P SLENDER GUIDING SHEATH. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 11SEPT2020. THE PROCEDURE PERFORMED FOR THE PATIENT AT THE TIME OF DIFFICULTY WAS FOR A STROKE. THERE WAS DIFFICULTY NOTED WHILE TRACKING FROM THE SUBCLAVIAN TO THE RCCA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10631648 ↗
• MalfunctionOct 5, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS UNABLE TO NAVIGATE THE INVOLVED DESTINATION TO SKULL BASE. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. THE PROCEDURE PERFORMED FOR THAT PATIENT WAS A NEURO INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPORTED DEVICE. THERE WAS NO DIFFICULTIES DURING ACCESS DUE TO PATIENT TORTUOUS ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10626263 ↗