DESTINATIONRecalls & reported problems across all models
Terumo Medical Corporation · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 223
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls
- 0
We found 21 models of DESTINATION by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 223 adverse event reports in the FDA's MAUDE database, received between May 13, 2016 and Mar 26, 2026 — classified as 63 injuries, 160 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (86 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DESTINATION problems
Device problems
- Material Deformation86
- Break28
- Difficult to Insert23
- Physical Resistance/Sticking20
- Detachment of Device or Device Component19
- Difficult to Advance14
- Material Separation14
- Leak/Splash13
Patient problems
- No Clinical Signs, Symptoms or Conditions111
- No Consequences Or Impact To Patient51
- Blood Loss29
- Foreign Body In Patient11
- No Patient Involvement9
- Hematoma8
- Insufficient Information4
- Device Embedded In Tissue or Plaque3
DESTINATION models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DESTINATION RSR01INTRODUCER, CATHETER55 reports
- DESTINATION 54-74501INTRODUCER, CATHETER44 reports
- DESTINATION RSC05INTRODUCER, CATHETER18 reports
- DESTINATION RSR04INTRODUCER, CATHETER16 reports
- DESTINATION 54-64501INTRODUCER, CATHETER16 reports
- DESTINATION 54-84501INTRODUCER, CATHETER15 reports
- DESTINATION 54-54501INTRODUCER, CATHETER11 reports
- DESTINATION RSP01INTRODUCER, CATHETER10 reports
- DESTINATION RSR03INTRODUCER, CATHETER8 reports
- DESTINATION 54-89001INTRODUCER, CATHETER6 reports
- DESTINATION RSC01INTRODUCER, CATHETER5 reports
- DESTINATION 54-86501INTRODUCER, CATHETER4 reports
- DESTINATION RSP02INTRODUCER, CATHETER3 reports
- DESTINATION RSR13INTRODUCER, CATHETER2 reports
- DESTINATION RSC07INTRODUCER, CATHETER2 reports
- DESTINATION RSC08INTRODUCER, CATHETER2 reports
- DESTINATION 54-54503INTRODUCER, CATHETER2 reports
- DESTINATION RSR02INTRODUCER, CATHETER1 report
- DESTINATION RSR06INTRODUCER, CATHETER1 report
- DESTINATION RSR07INTRODUCER, CATHETER1 report
- DESTINATION RSC06INTRODUCER, CATHETER1 report
Recent DESTINATION adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 27, 2025Material Separation; Material Separation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHEN THE PHYSICIAN TRIED TO REMOVE THE SHEATH, IT RIPPED. THEN THEY CUT THE SIDEARM PART OFF AND TRIED TO SLIDE A SMALLER DILATOR DOWN TO THE TIP OF THE SHEATH TO GET IT OUT. IT DID NOT WORK, AND THE PATIENT HAD TO GO TO THE HOSPITAL TO HAVE THE SHEATH REMOVED. ADDITIONAL INFORMATION WAS RECEIVED ON 09DEC2025: THE PROCEDURE FOR THE PATIENT AT THE TIME THE REPORTED ISSUE OCCURRED WAS A LEFT ANGIO. IT APPEARED THAT THERE MAY HAVE BEEN CALCIFICATION/TORTUOUS ANATOMY AT THE TIME THE DESTINATION DEVICE RIPPED AT THE TIP AS DESCRIBED WHEN TRYING TO REMOVE THE TIP OF THE SHEATH. THE PATIENT DID NOT EXPERIENCE SPASM AT THE TIME THE SHEATH RIPPED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND HAD A VASCULAR CUT DOWN. PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901623 ↗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 ↗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 ↗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 18, 2025Difficult to Remove; Stretched; Physical Resistance/Sticking; Difficult to Remove; Stretched; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. ACCESS WAS IN THE LEFT COMMON FEMORAL ARTERY WITH A 7FR X 45CM DESTINATION SHEATH. AFTER THE PROCEDURE WAS COMPLETE, THE SURGEON ATTEMPTED TO RETRACT THE SHEATH AND ENCOUNTERED RESISTANCE. HE FELT THAT THE SHEATH WAS STRETCHING OUT AND WAS NOT COMING OUT OF THE PATIENT. THE SURGEON DECIDED TO PERFORM A CUT-DOWN OF THE COMMON FEMORAL ARTERY (CFA)TO REMOVE THE SHEATH. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE TYPE WAS A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2025: THE PHYSICIAN STATED THAT HE DID NOT BELIEVE THERE WAS ANY ISSUE WITH THE SHEATH ITSELF, DURING THE CUT-DOWN HE FOUND THAT THE GROIN WAS VERY SCARRED AND BELIEVED IT WAS THE SCAR TISSUE THAT WAS RESISTING THE SHEATH FROM BEING REMOVED. THE PATIENT WAS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22547504 ↗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 ↗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 ↗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 ↗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 ↗InjuryJun 2, 2025Break; Material Separation; Break; Material Separation
THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH BROKE OFF IN THE PATIENT DURING THE PROCEDURE AND HAD TO BE SNARED OUT BY THE DOCTOR. ACCESS WAS VIA GROIN. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.
Patient problems: Foreign Body In Patient
MAUDE report 22125571 ↗InjuryMay 29, 2025Break; Material Fragmentation; Break; Material Fragmentation
THE USER FACILITY REPORTED THAT THE DETESTATION DEVICE EXPERIENCED FRAGMENTATION AND BREAKAGE OF THE PLASTIC COVERING OF THE INTRODUCER. ANOTHER DEVICE WAS USED, AND THERE WERE NO CONSEQUENCES OR PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 14 MAY 2025: THE PROCEDURE PERFORMED WAS A RECANALIZATION AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN CROSSOVER OF THE RIGHT POPLITEAL ARTERY AND ANTERIOR TIBIAL ARTERY (ATA) USING DRUG-ELUTING BALLOON (DEB) RANGER (4X120MM, 2.5X150MM). PTA OF THE SUPERFICIAL FEMORAL ARTERY (AFS) AT THE SITE OF PREVIOUS STENTING WAS PERFORMED USING ADVANCE (5X20MM). THE PATIENT'S ILIAC AXES WERE NOT TORTUOUS BUT SHOWED MULTIPLE CIRCUMFERENTIAL CALCIFICATIONS, NOT CAUSING HEMODYNAMICALLY SIGNIFICANT STENOSIS BILATERALLY. DURING THE PROCEDURE, NO VESSEL SPASMS WERE OBSERVED. IT WAS NOT NECESSARY TO CONVERT THE PROCEDURE TO TRADITIONAL SURGERY, BUT A SUPPORT GUIDE (LANDERQUIST 0.035) WAS REQUIRED TO RETRIEVE THE INTRODUCER FROM THE LEFT PERCUTANEOUS ACCESS, ALSO USING A SURGICAL INSTRUMENT TO AVOID LEAVING ANY PARTS OF THE DEVICE INSIDE THE PATIENT'S ARTERIAL AXIS. AN ANGIOGRAM WAS PERFORMED. BLOOD LOSS WAS UNQUANTIFIABLE, BUT THE PATIENT CERTAINLY LOS
Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding
MAUDE report 22110138 ↗InjuryMar 12, 2025Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT THE PATIENT DEVELOPED A LARGE HEMATOMA IN HIS RIGHT GROIN SHORTLY AFTER PLACING A 6F X 45 DESTINATION IN THE LEFT GROIN. THE FEMORAL ARTERY WAS FIRST ACCESSED USING ULTRASOUND AND MICRO PUNCTURE. A 6F SHEATH WAS PLACED, AND DIAGNOSTIC IMAGES DETERMINED AN INTERVENTION WAS NEEDED. THE SHORT SHEATH WAS EXCHANGED FOR A 6F DESTINATION. SOON AFTER, THE VASCULAR SURGEON RECOGNIZED A SIGNIFICANT HEMATOMA. A CONTRAST IMAGE WAS USED TO CONFIRM THE BLEED. IT WAS DIFFICULT TO DETERMINE IF IT WAS COMING FROM THE ACCESS SITE OR A NEARBY SIDE BRANCH. AFTER HOLDING MANUAL PRESSURE AND REDUCING THE HEMATOMA, THE VASCULAR SURGEON TRIED TO PROCEED; HOWEVER, THE HEMATOMA GREW, AND HE DECIDED TO ABORT THE PROCEDURE. UPON REMOVING THE DESTINATION, THE TECHNICIAN NOTICED A SLIGHT DEFORMITY AT THE DISTAL TIP OF THE SHEATH. IT IS UNDETERMINED IF IT WAS LIKE THIS UPON ENTERING THE BODY. IF SO, IT WOULD NOT HAVE BEEN A SMOOTH TRANSITION FROM THE DILATOR TO THE SHEATH AND COULD HAVE CONTRIBUTED. MANUAL PRESSURE WAS ADMINISTERED, AND HEMOSTASIS WAS ACHIEVED. THE REPORTED EVENT RESULTED IN PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. IT WAS INCONCLUSIVE AS TO
Patient problems: Hematoma
MAUDE report 21580539 ↗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 ↗
Other Terumo Medical Corporation products
All Terumo Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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