DESTINATION 54-89001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00389701009452), received between Jul 19, 2017 and Aug 16, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE TIP OF THE DESTINATION SHEATH WAS FLARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561696 ↗
• MalfunctionJul 9, 2023Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT RESISTANCE WAS FELT WHEN ADVANCING THE INVOLVED DESTINATION DEVICE INTO THE PATIENT. WHEN THEY WITHDREW THE PRODUCT, IT WAS FOUND THAT THE GUIDING SHEATH HAD A BROKEN DISTAL TIP. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: Insufficient Information

  MAUDE report 17284951 ↗
• InjuryAug 20, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  THE USER FACILITY REPORTED THAT AN 8FR DESTINATION SHEATH WAS INSERTED WITH THE DILATOR INTO THE STROKE PATIENT. WHEN REMOVING THE DILATOR FROM THE SHEATH, THE DILATOR GOT STUCK TO VALVE. THE VALVE RUPTURED AND CAUSED BLEEDING. WHEN REPLACING THE NEW SHEATH WITHIN 5 MINUTES THE PATIENT HAD A HEMATOMA IN THE GROIN. THE USER STATED THAT THE DILATOR WAS IN THE CENTER OF THE VALVE. THE PATIENT HAD MINOR HARM. PART OF THE HEMOSTASIS VALVE WAS CAUGHT ON THE DILATOR AND DETACHED FROM THE INTRODUCER. THE PATIENT WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE ESTIMATED BLOOD LOSS WAS 250CC. THE BLEEDING WAS STOPPED BY PRESSING THE PUNCTURE AREA BY HANDS AND CHANGING THE NEW INTRODUCER OVER THE WIRE. THE PATIENT WAS TREATED AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PROCEDURE PERFORMED WAS FOR A STROKE IN THE BRAIN. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BLOOD LOSS WAS APPROXIMATELY 250CC.

  Patient problems: Hematoma

  MAUDE report 15263418 ↗
• MalfunctionMay 19, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 06JUN2021. THE SHEATH BUCKLED AS OPPOSED TO PINCHED. THE CONDITION OF THE VASCULATURE OF THE PATIENT WAS STABLE. THE WAS AN OUT OF THE BOX FAILURE WITH NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850055 ↗
• MalfunctionMay 19, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 06JUN2021. THE SHEATH BUCKLED AS OPPOSED TO PINCHED. THE CONDITION OF THE VASCULATURE OF THE PATIENT WAS STABLE. THE WAS AN OUT OF THE BOX FAILURE WITH NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850053 ↗
• MalfunctionJul 19, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THE VALVE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THERE WAS EXCESSIVE LEAKING FROM THE VALVE. BLOOD LOSS WAS LESS THAN 250CC. IT WAS REPORTED THAT THE PATIENT WAS IN GOOD CONDITION AND THE PROCEDURE OUTCOME WAS GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 06/27/2017. THE VALVE WAS LEAKING WHEN THE WIRES WERE IN PLACE. IT APPEARED TO ONLY BE LEAKING WHEN TWO WIRES WERE INSERTED BUT THE OPERATOR STATED IT WAS ALSO LEAKING WITH ONE WIRE INSERTED. THE PROCEDURE WAS A SUCCESS AND PATIENT WAS STABLE.

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

  MAUDE report 6724267 ↗