DESTINATION RSR04Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00389701006192), received between Dec 21, 2016 and Mar 26, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryMar 26, 2026Material Separation; Unraveled Material

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5183131. THE MEDWATCH EVENT DESCRIPTION STATED THAT: "WHILE ATTEMPTING TO REMOVE ARTERIAL SHEATH 7FX45CM DESTINATION THE SHEATH BRAIDING BEGAN TO UNRAVEL AND CATHETER SEVERED. THIS REQUIRED AN ADDITIONAL INTERVENTION TO RETRIEVE THE SEVERED CATHETER PIECE FROM THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 24699264 ↗
• MalfunctionFeb 5, 2026Device Damaged Prior to Receipt by User

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CUSTOMER RECEIVED THE WRONG ITEM INSIDE OF THE CORRECT PACKAGING ON THE PURCHASE ORDER. THE ACCOUNT ORDERED 7FR RSR04 HOWEVER, RECEIVED 6FR 54-64501 INSIDE OF THE 7FR PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268086 ↗
• MalfunctionNov 5, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE RENAL SHEATH WAS USED WHEN A PERIPHERAL SHEATH SHOULD HAVE BEEN USED. THE SHEATH SNAGGED A STENT DUE TO THE LACK OF HYDROPHILIC COATING, AND IT ALSO SHEARED UPON REMOVAL. THE PATIENT WAS FINE, AND THE PROCEDURE WAS SUCCESSFUL. THER PROCEDURE WAS A PAD CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 17OCT2025: THE PRODUCT SHEERED AND BROKE AT THE PROXIMAL END ABOUT AN INCH DOWN FROM WHERE THE SHEATH AND DILATOR CONNECT. NOTHING WAS LEFT IN THE PATIENT. ALL PIECES WERE ABLE TO BE RETRIEVED. BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476944 ↗
• InjuryJul 2, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT A REGISTERED NURSE (RN) AND AN INTERVENTIONAL CARDIOLOGIST WERE PERFORMING A HEART CATHETERIZATION ON A PATIENT. DUE TO THE PATIENT'S TORTUOUS ILIAC ANATOMY, A 7FR X 45CM DESTINATION GUIDING SHEATH (RSR04) WAS UTILIZED TO PROVIDE ADDITIONAL SUPPORT DURING THE PROCEDURE. AT THE CONCLUSION, THE DESTINATION SHEATH WAS WITHDRAWN, AND IT BEGAN TO UNRAVEL NEAR THE TIP. A PORTION OF THE SHEATH BROKE OFF AND REMAINED IN THE PATIENT, NECESSITATING SURGICAL INTERVENTION FOR REMOVAL. THE SURGICAL INTERVENTION WAS SUCCESSFUL, AND THE PATIENT IS NOW STABLE. THE EVENT OCCURRED INTRA-OPERATIVELY. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Foreign Body In Patient

  MAUDE report 22391515 ↗
• InjuryJun 6, 2025Break; Material Separation; Break; Material Separation

  A TERRITORY MANAGER FROM ANOTHER COMPANY SENT AN IMAGE OF A DESTINATION SHEATH. THEY INDICATED THAT THE CASE WAS A JET-STREAM CASE WITH BOSTON SCIENTIFIC TO OUR TERUMO FIELD CLINICAL SPECIALIST. THE PROCEDURE WAS A PERIPHERAL ANGIOGRAM AND ARTHRECTOMY. THE PATIENT WAS STABLE AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 15MAY2025: THE SHEATH BROKE ON THE SHAFT AND THE BRAIDING WAS EXPOSED WHILE IN THE PATIENT. THE VASCULAR SURGEON WAS CERTAIN SHE REMOVED ALL OF THE SHEATH. A SECOND 7FR DESTINATION SHEATH WAS OPENED AND USED WITHOUT ANY DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160814 ↗
• InjuryNov 6, 2024Break; Material Deformation; Break; Material Deformation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT #(B)(4) . THE EVENT DESCRIPTION STATES: "7F DESTINATION RENAL GUIDING SHEATH (45CM REF- RSR04 LOT0000484177 EXP 7/1/2026) INSERTED INTO RIGHT FEMORAL ARTERY. PENUMBRA LIGHTNING BOLT 7 INDIGO SYSTEM 7F 130CM REF - LITNGBT7TQ130 LOT H00004313 EXP 1/1/2027) INSERTED THROUGH DESTINATION SHEATH (MENTIONED ABOVE) FOR PLACEMENT IN THE LEFT LOWER EXTREMITY (LLE) ARTERY. DURING USE, THE SURGEON NOTED HE WAS UNABLE TO ADVANCE THE CATHETER. IMAGING WAS TAKEN AND MD NOTED A KINK IN THE CATHETER AND SHEATH. MD ATTEMPTED TO ADVANCE A WIRE THROUGH CATHETER BUT WAS UNSUCCESSFUL. WHILE ATTEMPTING TO REMOVE THE CATHETER AND SHEATH, BOTH DEVICES BROKE INTO TWO PIECES (FOUR TOTAL). ALL PIECES SUCCESSFULLY EXTRACTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : POPLITEAL ARTERY REVASCULARIZATION ENDOVASCULAR WITH ANGIOPLASTY TRANSCATHETER THERAPY, CESSATION OF THROMBOLYSIS INCLUDING REMOVAL OF CATHETER AND VESSEL CLOSURE BY ANY METHOD. PRIMARY PERCUTANEOUS TRANSLUMINAL MECHANICAL THROMBECTOMY, NONCORONARY, NON-INTRACRANIAL, ARTERIAL OR ARTERIAL BYPASS GRAFT, INCLUDING THROMBOLYTIC INJECTION(S); INITIAL VESSEL TRANSCATHETER RETRIEVAL, PERCUTANEOUS, OF INTRAV

  Patient problems: Foreign Body In Patient

  MAUDE report 20617454 ↗
• MalfunctionOct 7, 2024

  7F DESTINATION RENAL GUIDING SHEATH (45CM REF- RSR04 LOT0000484177 EXP 7/1/2026) INSERTED INTO RIGHT FEMORAL ARTERY. PENUMBRA LIGHTNING BOLT 7 (INDIGO SYSTEM 7F 130CM REF - LITNGBT7TQ130 LOT H00004313 EXP 1/1/2027) INSERTED THROUGH DESTINATION SHEATH (MENTIONED ABOVE) FOR PLACEMENT IN THE LEFT LOWER EXTREMITY (LLE) ARTERY. DURING USE, THE SURGEON NOTED HE WAS UNABLE TO ADVANCE THE CATHETER. IMAGING WAS TAKEN AND MD NOTED A KINK IN THE CATHETER AND SHEATH. MD ATTEMPTED TO ADVANCE A WIRE THROUGH CATHETER BUT WAS UNSUCCESSFUL. WHILE ATTEMPTING TO REMOVE THE CATHETER AND SHEATH, BOTH DEVICES BROKE INTO TWO PIECES (FOUR TOTAL). ALL PIECES SUCCESSFULLY EXTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385148 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL ARTERIAL DISEASE (PAD) PROCEDURE VIA RIGHT LEG ACCESS FROM THE LEFT COMMON FEMORAL ARTERY (CFA), THE DESTINATION DEVICE INVOLVED WAS ADVANCED UP AND OVER A VERY CALCIFIED AND STEEP BIFURCATION. THE PROCEDURE WAS COMPLETED BUT UPON REMOVAL OF THE DEVICE, THE SHEATH SKIN TORE EXPOSING THE COIL INSIDE. HEMOSTASIS WAS ACHIEVED WITH AN 8FR ANGIO-SEAL. THE PROCEDURE WAS COMPLETED. THE EVENT OCCURRED INTRA-OPERATIVE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14770828 ↗
• InjuryJan 6, 2022Separation Problem; Separation Problem

  THE USER FACILITY REPORTED THAT DURING A RIGHT LEG INTERVENTION VIA LEFT COMMON FEMORAL APPROACH, THE DESTINATION SHEATH WAS STUCK AND WHEN THE SHEATH WAS PULLED IT SEPARATED. A CUT DOWN WAS PERFORMED, AND THE SHEATH WAS REMOVED. THE PATIENT WAS CLOSED; HOWEVER, THEN RETURNED FOR A LEFT LEG ANGIOGRAM VIA THE RIGHT COMMON FEMORAL ARTERY BECAUSE THE BELOW KNEE ARTERIES HAD CLOTTED OFF. THE BLOOD LOSS WAS GREATER THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED 14-DECEMBER-2021: THE INNER COIL WAS EXPOSED. THE USER FACILITY STATED THEY SUSPECT THAT THE ACCESS MAY HAVE BEEN THROUGH A PREVIOUS SELF-EXPANDING STENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13180102 ↗
• MalfunctionMar 19, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION SHEATH WAS DAMAGED DURING THE PROCEDURE; CRIMPED OR KINK. THE PATIENT'S WELLBEING WAS NOT AFFECTED DUE TO THE DAMAGED PRODUCT. THE CONDITION OF THE PATIENT WAS GOOD, AND THE PROCEDURE OUTCOME WAS GOOD. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528057 ↗
• MalfunctionDec 17, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION RENAL GUIDING SHEATH DEVICE DISTAL END OF THE INTRODUCER ABRADED ON REMOVAL FROM THE PACKAGE, AND DM CANNOT BE INTRODUCED INTO THE PATIENT, THE DEVICE WAS CHANGED BY OPENING A SECOND ONE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11026952 ↗
• InjurySep 1, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH COULD NOT BE INTRODUCED INTO AN ILIOFEMORAL BYPASS. IT GOT STUCK ON THE ANTERIOR BYPASS-WALL AND GOT CRUSHED. THE USER WAS NOT PLEASED BY THE TRANSITION OF THE DILATOR TO THE SHEATH. THE DILATOR SHOULD BE LONGER TO HAVE MORE GUIDING OF THE DEVICE ON THE WIRE. THE PROCEDURE WAS FINALIZED WITH A SHEATH BY BIOTRONIK AS INTENDED. THERE WAS NO SIGNIFICANT DELAY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 11AUG2020: IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INSERT THE SHEATH. THE ISSUE WAS NOT PROCEDURE RELATED.

  Patient problems: Hematoma

  MAUDE report 10476976 ↗
• MalfunctionDec 20, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH BROKEN AT THE HUB BEFORE USAGE. THERE WERE NO COMPLICATIONS, THE PRODUCT WAS NOT USED. THERE WERE NO OTHER DEVICE OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 09 DEC 2019. THE PROCEDURE FOR PATIENT WAS PERIPHERAL INTERVENTION. THE ISSUE WAS RESOLVED TO CONTINUE THE PROCEDURE AS INTENDED, BY EXCHANGING FOR A NEW SHEATH. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502631 ↗
• MalfunctionSep 19, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION WAS ADVANCED OVER 035 WIRE; HOWEVER, COULD NOT GET THROUGH THE SCAR TISSUE AND KINKED THE DILATOR IN THE PROCESS. THE TRACK WAS THEN DILATED UP LARGER AND A NEW DESTINATION WAS ADVANCED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY; PATIENT WAS IN STABLE CONDITION; NOTHING RELATED TO THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087412 ↗
• InjuryJun 26, 2019Break; Break

  THE USER FACILITY REPORTED THAT WHEN THE PHYSICIAN WAS PERFORMING A LOWER EXTREMITY ANGIO WITH INTERVENTION AND STENT PLACEMENT THEY ATTEMPTED TO REMOVE THE DESTINATION SHEATH FROM THE FEMORAL ACCESS SITE, IT WAS OBSERVED THAT THE SHEATH WAS BREAKING IN TWO PLACES. THE PHYSICIAN THEN INSERTED A COOK SHEATH G56220 TO HELP SUPPORT THE REMOVAL. BOTH SHEATHS WERE REMOVED AND CONFIRMED THAT THE DESTINATION SHEATH HAD SEPARATION IN TWO SPOTS. A NEW SHEATH WAS INSERTED, AND AN ABBOTT OMNILINK STENT WAS PLACED WITHOUT INCIDENT. THE PATIENT WAS NOT AFFECTED, AND THE CASE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736579 ↗
• MalfunctionDec 21, 2016Fracture; Fracture

  THE USER FACILITY REPORTED THE DESTINATION DEVICE UN-RAVELED DURING A CASE. FOLLOW UP COMMUNICATIONS WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DESTINATION DEVICE UN-RAVELED UPON REMOVAL FROM THE PATIENT AT THE END OF A CASE; IT WAS CONFIRMED THAT NO PORTION OF THE PRODUCT WAS LEFT IN THE PATIENT; A 6FR COOK ANSEL WAS REMOVED AND 7FR DESTINATION WAS INSERTED; THE CASE WAS PERFORMED AS PLANNED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WERE NO PATIENT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6195050 ↗