DESTINATION RSR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00389701006161), received between Apr 26, 2018 and Dec 5, 2025 — classified as 13 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Material Fragmentation; Material Fragmentation

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. DURING A PERIPHERAL ANGIOGRAM INTERVENTION, A DESTINATION 6X45CM SHEATH SNAPPED IN HALF AND UNRAVELED IN THE PATIENT WHILE TRYING TO REMOVE THE SHEATH AND DILATOR FROM THE PATIENT. THE VASCULAR SURGEON THEN NEEDED TO PERFORM A CUT DOWN TO REMOVE THE SHEATH. THE BLOOD LOSS WAS LESS THAN 250CC. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE DESTINATION DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 17NOV2025: THE DILATOR DID NOT SNAP IN HALF. THE SHEATH UNRAVELED AND BROKE APART.

  Patient problems: Foreign Body In Patient

  MAUDE report 23728950 ↗
• InjuryMar 11, 2025Solder Joint Fracture; Solder Joint Fracture

  THE USER FACILITY REPORTED THE BREAKAGE OF THE INTRODUCER DURING TRACTION WHILE REMOVING THE MATERIAL. THE PATIENT SUSTAINED NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569682 ↗
• InjuryNov 29, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 15 JAN 2025: NO OTHER DEVICE WAS USED WITH METALLIC COILING WAS USED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20808615 ↗
• MalfunctionNov 15, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE DILATOR WOULD NOT GO IN THE SHEATH. THE PROCEDURE WAS A PERIPHERAL PROCEDURE. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700725 ↗
• MalfunctionOct 10, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) VIA FEMORAL ACCESS. PUNCTION WAS PERFORMED BY SELDINGER TECHNIQUE AND INSERTION OF A LUNDERQUIST GUIDE WIRE WAS DONE. WHEN ADVANCING THE RSR01 THE DILATOR ENTERED THE VESSEL WITHOUT RESISTANCE, WHEN ADVANCING THE SHEATH INTO THE VESSEL RESISTANCE WAS FELT. THE TIP OF THE SHEATH SEEMED TO ROLL UP DUE TO THE RESISTANCE. THE PATIENT CONDITION WAS STABLE AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 01OCT2024: A 6 FRENCH PROCEDURE SHEATH WAS USED. THERE WERE NO ISSUES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. IT WAS UNKNOWN IF A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE. HEMOSTASIS WAS ACHIEVED BY THE ANGIO-SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417046 ↗
• MalfunctionOct 3, 2024Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT WHEN THEY WERE REMOVING THE 6FR 45CM DESTINATION SHEATH IT HAD GOT STUCK IN THE PATIENT'S FEMORAL ARTERY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360901 ↗
• InjuryJan 26, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED ON 08FEB2024: THE PROCEDURE TAKING PLACE WHEN THE LEAKAGE OCCURRED BECAUSE OF VALVE DISCONNECT WAS CARDIAC CATHETERIZATION. THE PATIENT HAD A LOT OF TORTUOSITY WHICH WAS WHY THE DOCTOR CHOSE THE SIZE OF THE DESTINATION (DS) SHEATH HE DID, HOWEVER THEY WERE LEAKING MULTIPLE TIMES, AND A VERY SMALL HEMATOMA OCCURRED DURING THE MULTIPLE EXCHANGES OF DEVICES. THE HEMATOMA WAS RESOLVED WITH MANUAL PRESSURE AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Hematoma

  MAUDE report 18591546 ↗
• InjuryJan 26, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED THAT DURING THE PROCEDURE IT WAS DISCOVERED THAT THE HUB OF THE DESTINATION SHEATH WOULD NOT TIGHTEN ADEQUATELY AND AS NORMAL AND AS A RESULT LEAKED BLOOD. ANOTHER DESTINATION SHEATH WITH A DIFFERENT LOT NUMBER WAS OPENED BUT WAS ALSO FOUND TO HAVE THE SAME ISSUE. FINALLY, A COMPETITOR DEVICE, MANUFACTURED BY CORDIS, WAS USED WITH SUCCESS. THE DOCTOR STATED THAT THE DEFECTIVE DEVICE CAUSED A HEMATOMA. BLOOD LOSS LESS THAN 250 CCS. THE EVENT OCCURRED INTRA-OPERATIVE. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE IS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: Hematoma

  MAUDE report 18585667 ↗
• MalfunctionJan 12, 2024Material Frayed; Material Deformation; Material Frayed; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 17 JAN 2024: THE PROCEDURE PERFORMED FOR THE PATIENT AT THE TIME THE DIFFICULTY WITH DESTINATION OCCURRED WAS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CROSSOVER. PROCEDURE SHEATH SIZE USED WAS A 6F. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. AN ANGIOGRAM WAS NOT PERFORMED. THERE WAS NO REPORTED BLOOD LOSS. PATIENT CONDITION IS STABLE. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE INVOLVED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508753 ↗
• MalfunctionAug 18, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN INTRODUCED THE DESTINATION SHEATH INTO THE ARTERY AND THE DISTAL TIP OF THE SHEATH GOT DAMAGED. THE PHYSICIAN DOES NOT REMEMBER IF SHE DID A SMALL OF THE SKIN AT THE PUNCTURE SITE. THERE WAS NO SIGNIFICANT LOSS OF BLOOD. A SHORT FEMORAL SHEATH (IK B 6F) WAS USED TO ENLARGE THE PUNCTURE SITE. THEN THE DESTINATION SHEATH WAS USED AND COULD BE PLACED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571176 ↗
• InjuryJul 14, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH WAS USED SUCCESSFULLY TO PERFORM A SUPERFICIAL FEMORAL ARTERY (SFA) PERIPHERAL INTERVENTION. WHEN FINISHING THE PROCEDURE AND REMOVING THE SHEATH FROM THE PATIENT'S FEMORAL ARTERY THERE WAS RESISTANCE AND THE SHEATH ENDED UP SPLITTING IN TWO. THE PHYSICIAN WAS ABLE TO REMOVE BOTH PIECES WITH NO HARM TO THE PATIENT. THE PATIENT WAS STABLE AND DOING FINE WITH NO COMPLICATIONS. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 16JUN2023: THE ANATOMY WAS NOT VERY TORTUOUS; HOWEVER, THEY DID GET RESISTANCE. THE PHYSICIAN WAS ABLE TO REMOVE THE PIECES WITHOUT SURGICAL INTERVENTION. THE LOCATION OF THE SPLIT ON THE DESTINATION WAS 10 CM PROXIMAL OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325974 ↗
• MalfunctionJun 5, 2023Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THEY WERE UNABLE TO MOUNT THE DESTINATION INTRODUCER IN THE ARTERY, THE DILATOR COMES OUT LESS THAN USUAL FROM THE INTRODUCER. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 24MAY2023: THE PROCEDURE WAS A RIGHT ILIAC ANGIOPLASTY AND RIGHT FEMORAL TRIPOD BY CROSSOVER. THE DEVICE DID NOT APPEAR TO BE DAMAGED. THERE WAS NO STENOSIS, PLAQUE, CALCIUM PRESENT AROUND THE INSERTION SITE. THE PATIENT CONDITION WAS STABLE. ANOTHER INTRODUCER OF THE SAME REFERENCE WAS USED TO COMPLETE THE PROCEDURE AND WAS COMPLIANT. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056677 ↗
• MalfunctionFeb 2, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE GUIDING SHEATH OF THE DESTINATION DEVICE INVOLVED LEAKED, AND ALL THE CONTRAST MEDIA CAME OUT. AT THE BEGINNING, THE GUIDING SHEATH WAS OKAY; HOWEVER, AFTER ABOUT THIRTY (30) MINUTES THE USER WAS NOT ABLE TO APPLY CONTRAST MEDIA (CM). SUDDENLY, THERE WAS A HOLE. THROUGH THE HOLE, ABOUT 20 MILLIMETERS (ML) OF CM CAME OUT. THE PATIENT WAS OKAY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283092 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE WHILE OPENING A 6 FR DESTINATION SHEATH IT HAPPENED THAT THE CCV WITH THE SIDE PORT WAS LOOSE IN THE PACKING. DURING OPENING (OF THE PACKING) IT FELL OUT OF THE PACKING AND ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615650 ↗
• MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN OPENING THE DESTINATION, THE SIDE PORT WAS NOT DETACHED TO THE SHEATH. AS A RESULT, THE SIDE PORT FELL OUT AND BECAME UNSTERILE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287465 ↗
• MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN OPENING THE DESTINATION, THE SIDE PORT WAS NOT DETACHED TO THE SHEATH. AS A RESULT, THE SIDE PORT FELL OUT AND BECAME UNSTERILE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287451 ↗
• MalfunctionJan 21, 2021Material Deformation; Material Deformation

  EVALUATION OF THE ACTUAL SAMPLE REVEALED THAT THE TIP OF THE DESTINATION SHEATH WAS DAMAGED IN A FASHION WHERE THERE ARE FOLDS AND A BULGE ON THE EDGE OF THE SHEATH. THE DILATOR WAS NOT DAMAGED. THE USER FACILITY REPORTED THAT UPON REMOVAL OF THE DESTINATION SHEATH FROM THE CASING THEY DISCOVERED THE DILATOR WOULD NOT FLUSH. THE PATIENT'S CONDITION WAS FINE, AND THE PROCEDURE WAS A SUCCESS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 05NOV2020. THE PROCEDURE WAS A LEG ANGIO. THEY CONTINUED BY USING SECOND SAME DEVICE. THEY SAID THERE WAS NO HOLE. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 18DEC2020. THE DILATOR WOULD NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207940 ↗
• MalfunctionJan 11, 2021Break; Break

  THE USER FACILITY REPORTED THAT UPON OPENING THE DESTINATION PACKAGE IT WAS NOTICED THAT THE TIP OF THE DILATOR WAS BROKEN. IT WAS NOT INVOLVED WITH THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. THEY OPENED A SECOND (B)(4) TO CONTINUE THE PROCEDURE AS INTENDED. THEY FINISHED THE LEFT GROIN ACCESS PERIPHERAL LEG PROCEDURE AND COMPLETED THE CASE. THE PATIENT'S CONDITION WAS STABLE, AT THE TIME OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146564 ↗
• MalfunctionJan 8, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH WAS KINKED AT THE DISTAL TIP. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT CONDITION WAS FINE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 18DEC2020. THE KINK IN DISTAL SHEATH WAS DISCOVERED WHEN IT WAS OPENED. THE PROCEDURE BEING PERFORMED WAS A LEG ANGIO. THEY RESOLVED THE ISSUE WITH A NEW SHEATH. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139909 ↗
• MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHILE CAREFULLY OPENING A 6 FR DESTINATION SHEATH THE CCV WITH THE SIDE-PORT FELL OUT OF THE PACKAGE ON THE FLOOR. IT SEEMED TO BE COMPLETELY LOOSE IN THE STERILE PACKAGE. A SECOND DESTINATION SHEATH WAS OPENED AND USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095543 ↗
• MalfunctionDec 10, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE USER EXPERIENCED DAMAGE ON A DESTINATION 6X45 CM SHEATH WHILE PULLING IT OUT AT THE END OF THE PROCEDURE. THE SHAFT OF THE SHEATH WAS BROKEN INTO TWO PIECES, AND THE BRAIDING WIRE WAS THE ONLY THING UNBROKEN. ADDITIONAL INFORMATION WAS RECEIVED ON 02DECEMBER2020: THE PROCEDURE BEING PERFORMED WAS AN ARTERY FEMORALIS SUPERFICIALIS (AFS) CLOSURE. THERE ARE NO BROKEN SHEATH PIECES IN THE PATIENT. THERE WAS NO BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER THE SHEATH WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987600 ↗
• MalfunctionDec 2, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING SURGERY THE DESTINATION CATHETER TIP WAS NOT SMOOTH ENOUGH TO GO THROUGH THE VESSELS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL AS THEY USED THE SAME PRODUCT TO FINISH THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 09NOV2020. TWO DEVICES WERE USED IN THE CASE THAT DISPLAYED THE SAMPLE ISSUE WITH THE EDGE OF THE CATHETER TIP NOT BEING SMOOTH ENOUGH TO GO THROUGH THE VESSEL. THERE WAS NO REPORTED PATIENT ISSUE AS THE SURGEON WAS ABLE TO SUCCESSFULLY USE A THIRD DEVICE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935074 ↗
• MalfunctionDec 2, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING SURGERY THE DESTINATION CATHETER TIP WAS NOT SMOOTH ENOUGH TO GO THROUGH THE VESSELS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL AS THEY USED THE SAME PRODUCT TO FINISH THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 09NOV2020. TWO DEVICES WERE USED IN THE CASE THAT DISPLAYED THE SAMPLE ISSUE WITH THE EDGE OF THE CATHETER TIP NOT BEING SMOOTH ENOUGH TO GO THROUGH THE VESSEL. THERE WAS NO REPORTED PATIENT ISSUE AS THE SURGEON WAS ABLE TO SUCCESSFULLY USE A THIRD DEVICE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935036 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT A NURSE HAD CARRIED OUT A MATERIAL VIGILANCE ON A LONG INTRODUCER 6FR 45CM DESTINATION STRAIGHT DEVICE, THE INTRO WOULD HAVE BEEN TOTALLY DEFORMED UP TO 90 CM (IT HAD LENGTHENED). THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10794648 ↗
• MalfunctionOct 22, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION CATHETER WAS DEFECTIVE. NO GUIDE WIRES WOULD PASS THROUGH THE INTRODUCER. THE PATIENT CONDITION IS GOOD. THERE WAS NO MEDICAL INTERVENTION. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 02OCTOBER2020: THE PROCEDURE WAS AN ANGIOGRAM OF THE LEGS. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED WITH A NEW DESTINATION. THERE WAS NO BLOOD LOSS. THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10720555 ↗