DESTINATION RSR02Recalls & reported problems
Terumo Medical Corporation · DESTINATION Renal Guiding Sheath · Class 2
All models of DESTINATION (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701006178), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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