DESTINATION RSR03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00389701006185), received between Sep 13, 2017 and Dec 18, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Material Separation; Material Separation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CATH LAB HAD A COMPLETELY SHREDDED DESTINATION, WHICH WAS MULTI-FRACTURED AND BROKEN INTO TWO PIECES. AFTER THE FEMORAL PUNCTURE, PROBLEMS AROSE WHEN PULLING OUT THE SHEATH, THE DESTINATION CAME LOOSE IN PARTS, AND THE DISTAL PART WAS SAVED WITH THE HELP OF A BALLOON. ALL PARTS OF THE DESTINATION DEVICE COULD BE COLLECTED. THE INTERVENTION TOOK LONGER; HOWEVER, THE PATIENT DID NOT SUFFER ANY DAMAGE, AND THERE WAS NO BLEEDING OR HEMATOMA. THE PUNCTURE WAS CLOSED WITH AN ANGIO-SEAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23839245 ↗
• MalfunctionJul 1, 2024Connection Problem; Connection Problem

  THE USER FACILITY REPORTED THAT THE VALVE WAS LEAKING AT THE LEVEL OF THE "SCREW." PROCEDURE TYPE WAS A VISCERAL EMBOLIZATION. THERE IS NO DIRECT CLAIM THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 05 JUN 2024: THE DESTINATION WAS UTILIZED TO FINALIZE THE PROCEDURE. LEAKAGE WAS OBSERVED MIDWAY THROUGH THE PROCEDURE. THE PATIENT REMAINS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641172 ↗
• InjuryMay 8, 2022Material Separation; Unraveled Material; Physical Resistance/Sticking; Material Separation; Unraveled Material; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PATIENT RECEIVED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE UPPER AND LOWER LEG. DURING THE PROCEDURE THE PHYSICIAN NOTICED A CALCIFIED PUNCTURE SITE. AFTER THE SUCCESSFUL TREATMENT OF THE DIFFERENT CLOSURES, THE DOCTOR WANTED TO PULL BACK THE DESTINATION GUIDING SHEATH. HE NOTICED A HIGHER RESISTANCE AS HE INTRODUCED THE SHEATH, DUE TO THE CALCIFIED PUNCTURE SITE. HE INCREASED THE FORCE JUST A LITTLE BIT AND SUDDENLY THE SHEATH TORE INTO TWO PIECES, STILL CONNECTED WITH THE BRAIDED INNER WIRE. THE DISTAL PART WAS STILL IN THE PATIENT AND JUST A LITTLE PIECE SHOWED UP OVER THE SKIN. THE PHYSICIAN WAS ABLE TO GRAB THE DISTAL PART WITH A TWEEZER AND PULLED IT COMPLETELY OUT OF THE PATIENT. AFTER THAT HE REMOVED THE 0.035" WIRE AND CLOSED THE PUNCTURE SITE WITH MANUAL COMPRESSION, NOT WITH AN ANGIO-SEAL AS MENTIONED IN THE REPORT. THE PATIENT HAS BEEN TREATED AS INTENDED. THERE WAS NO SIGNIFICANT DELAY OF THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 13 APR 2022: THE PHYSICIAN DID NOT MENTION A TORTUOUS ANATOMY, HE MENTIONED A HIGHER RESISTANCE DURING THE INSERTION AND THE WITHDRAW DUE TO A CALCIFIED VESSEL. THERE WAS NO PATIENT SP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332449 ↗
• InjuryOct 24, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD INDICATED THAT DURING THE PROCEDURE HE NOTICED A HEMATOMA FORMING ON THE GROIN AFTER THEY HAD SWAPPED OUT THE PINNACLE SHEATH FOR A 6FR DESTINATION. THE REGISTERED RADIOLOGIC TECHNOLOGIST RT(R) IN THE ROOM, WAS ALERTED AND HELD PRESSURE ON THE HEMATOMA DURING PROCEDURE. UPON REMOVAL OF THE SHEATH, THE DOCTOR STATED HE NOTICED SOMETHING DIFFERENT ON THE DISTAL END OF SHEATH THAT FELT BURR LIKE AND WAS VISIBLE ON DISTAL END OF SHEATH. THE STAFF CONTINUED TO HOLD PRESSURE TO RESOLVE THE HEMATOMA. THE PATIENT WAS GOOD AND IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 06OCT2021. THE CASE WAS A PERIPHERAL INTERVENTION.

  Patient problems: Hematoma

  MAUDE report 12686897 ↗
• InjuryMar 4, 2021Material Separation; Stretched; Unraveled Material; Physical Resistance/Sticking; Material Separation; Stretched; Unraveled Material; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 31MAR2021. THE CONDITION OF THE VASCULATURE OF THE PATIENT WAS LT CRITICAL LIB ISCHEMIA WITH ILIAC AND SFA DISEASE. THERE WAS CALCIFIED ARTERIES AND SCARRED GROIN. BEFORE THE WIRE BRAIDING CAME OUT, THERE WAS SOME RESISTANCE WAS THEY TRIED TO PULL THE SHEATH BACK, THE SOURCE OF RESISTANCE WAS NOT IDENTIFIED. THE SHEATH WAS PUT FIRST ON THE DILATOR THEN DILATOR WAS REMOVED TO TAKE ANGIO AND DO THE ANGIOPLASTY. THERE WAS NOT A CATHETER WITHIN THE SHEATH. THERE WAS NO CATHETER, THERE WAS WIRE ONLY. THE BODY OF THE SHEATH SHORTLY AFTER TIP WAS BROKEN THROUGH PLASTIC COVER BUT THE SUPPORTING WIRE KEPT IT ATTACHED. THE SHEATH GOT CAUGHT IN THE LT EIA. IT IS BELIEVED THAT THE SUPPORT WIRE OF THE SHEATH SHEARED OFF OF THE TIP OF THE AMPLATZ GUIDEWIRE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11410592 ↗
• MalfunctionSep 16, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION WAS USED DURING A PTA-STENTING PROCEDURE. THE LESION WAS SITUATED IN THE AFS AT THE RIGHT SIDE. THE PUNCTURE SITE WAS IN THE LEFT COMMON FEMORAL ARTERY (CFA). AT THE PUNCTURE SITE THERE WERE NO CALCIFICATIONS, DUE TO AN EARLIER SURGICAL PROCEDURE THE PUNCTURE SITE WAS HEAVILY FIBROTIC. DURING INSERTION OF THE DESTINATION GUIDING SHEATH FRICTION WAS FELT. AFTER IT WAS IN POSITION THE CHARGER PTA CATHETER WAS ADVANCED WITHOUT PROBLEMS. WHILE RETRIEVING THE CHARGER CATHETER FRICTION WAS FELT. WHEN RETRIEVING THE DESTINATION SHEATH A LOT OF RESISTANCE WAS FELT, ESPECIALLY IN THE FIRST STAGE WHEN THE DESTINATION WAS STILL IN POSITION OVER THE BIFURCATION. WHEN RETRIEVED IT COULD BE SEEN THAT THE GUIDING SHEATH WAS DAMAGED. IN FACT, IT WAS NEARLY CUT THROUGH TOTALLY EXCEPT FOR THE BRAIDING. THE OPERATOR ADDED THAT THE DAMAGE WAS PROBABLY CAUSED BY THE FIBROSIS/SCAR TISSUE AT THE PUNCTURE SITE. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 28AUG2020. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED WITH THE DESTINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10540083 ↗
• MalfunctionSep 23, 2019Material Frayed; Physical Resistance/Sticking; Material Frayed; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE UPON INSERTION OF THE DESTINATION SHEATH, THE PHYSICIAN FELT RESISTANCE SO HE REMOVED IT. THE END OF THE SHEATH HAD FRAYED, WHICH WAS CAUSING THE RESISTANCE. THE SHEATH WAS RETAINED, AND A NEW ONE WAS USED WITHOUT ISSUES. ADDITIONAL INFORMATION WAS RECEIVED 30AUGUST2019: THE TYPE OF PROCEDURE PERFORMED WAS A RLE ANGIOGRAM, POSS. ILIAC STENT AND POSS. ATHERECTOMY. ANOTHER DESTINATION SHEATH WAS USED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE BLOOD LOSS WAS MINIMAL.

  Patient problems: Blood Loss

  MAUDE report 9106945 ↗
• MalfunctionSep 13, 2017Detachment Of Device Component; Detachment Of Device Component; Component Falling; Contamination; Loose or Intermittent Connection

  THE USER FACILITY REPORTED THAT WHEN THE CIRCULATOR OPENED THE PACKAGE TO HAND OFF TO THE TECH SCRUBBED IN TO THE STERILE FIELD. THE VALVE WAS NOT PROPERLY ATTACHED TO THE SHEATH AND FELL TO THE FLOOR. THEY HAD TO OPEN A NEW SHEATH AS THE OTHER HAD BECOME CONTAMINATED. IT APPEARS THERE ARE NO PHYSICAL DEFECTS TO THE SHEATH. THE VALVE JUST BECAME LOOSE. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THE PROCEDURE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED AN ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC.

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

  MAUDE report 6862345 ↗