DESTINATION 54-54501Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00389701008912), received between Apr 27, 2017 and Aug 21, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THEY HAD TWO DESTINATION SHEATHS THAT THE LUER LOCK WOULD NOT LOCK. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUL2024: TWO DEVICES WERE ON THE SHELF. THEY USED THE SECOND ONE FOR THE PROCEDURE AND THE IR DOCTOR WAS GENTLE WITH IT. THE LUER LOCK IT DID SEAT IN THERE, HOWEVER, THE SCREW PART WOULD NOT TIGHTEN AND CATCH. THE PROCEDURE BEING PERFORMED WAS A RENAL ANGIOGRAM. THE SECOND DEVICE, FROM THE SAME LOT NUMBER HAD THE SAME RESULT HOWEVER THEY MADE IT WORK. THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019946 ↗
• MalfunctionOct 6, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT UPON OPENING THE PACKAGING OF THE DESTINATION PRODUCT, IT WAS NOTICED THAT THE GREY TIP OF THE DESTINATION HAS LIFTED OFF OR IS COMING OFF FROM THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT OF EVENT ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18SEP2023: THE DEVICE WAS NOT USED ON THE PATIENT. THE PATIENT WAS STABLE. THERE WAS NO KNOWN AFFECT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19SEPT2023: IT WAS CONFIRMED THAT THE PRODUCT WAS NOT USED ON THE PATIENT AND THERE IS NO KNOWN EFFECT ON THE PATIENT AS IT WAS DISCOVERED UPON RECEIPT/PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885959 ↗
• MalfunctionOct 6, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT UPON OPENING THE PACKAGING OF THE DESTINATION PRODUCT, IT WAS NOTICED THAT THE GREY TIP OF THE DESTINATION HAS LIFTED OFF OR IS COMING OFF FROM THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT OF EVENT ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18SEP2023: THE DEVICE WAS NOT USED ON THE PATIENT. THE PATIENT WAS STABLE. THERE WAS NO KNOWN AFFECT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19SEPT2023: IT WAS CONFIRMED THAT THE PRODUCT WAS NOT USED ON THE PATIENT AND THERE IS NO KNOWN EFFECT ON THE PATIENT AS IT WAS DISCOVERED UPON RECEIPT/PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885951 ↗
• MalfunctionOct 6, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT UPON OPENING THE PACKAGING OF THE DESTINATION PRODUCT, IT WAS NOTICED THAT THE GREY TIP OF THE DESTINATION HAS LIFTED OFF OR IS COMING OFF FROM THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT OF EVENT ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18SEP2023: THE DEVICE WAS NOT USED ON THE PATIENT. THE PATIENT WAS STABLE. THERE WAS NO KNOWN AFFECT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19SEPT2023: IT WAS CONFIRMED THAT THE PRODUCT WAS NOT USED ON THE PATIENT AND THERE IS NO KNOWN EFFECT ON THE PATIENT AS IT WAS DISCOVERED UPON RECEIPT/PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885900 ↗
• MalfunctionJul 20, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DESTINATION TIP WAS BENT AT THE DISTAL END. THE PATIENT WAS IN STABLE CONDITION. PROCEDURE WAS COMPLETE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUNE2021: THE PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC ANGIO. DOCTOR STATED THAT THE TIP OF THE SHEATH WAS BENT, NOT THE DILATOR. IT WAS IRREGULAR AND BROKE ON THE DILATOR. PROCEDURE WAS COMPLETED BY A NEW DESTINATION SHEATH. THERE WAS NO DAMAGE NOTICED PRIOR TO THE DEVICE BEING USED. NO HARM TO THE PATIENT AND NO PROCEDURE DELAY. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE DESTINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197504 ↗
• MalfunctionMar 30, 2021Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS A LEFT BRACHIAL APPROACH TO ADDRESS IN-STENT BRACHIAL RESTENOSIS AND THEN TO PROCEED WITH A RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. THEY REPORTED THAT THE DESTINATION SHEATH WOULD NOT CROSS. OTHER DEVICES USED FOR THE PROCEDURE INCLUDED A PINNACLE SHEATH, GLIDEWIRE ADVANTAGE, 149CM DESTINATION SLENDER, LASER SPECTRANETICS, NANAOCOSS 5 X 100, 6 X 80 BALLOONS, AND A 6 X 80 EVERCROSS STENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A TECHNICAL SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 12MAR2021. WHEN THEY HAD DIFFICULTY WITH CROSSING, THEY RESOLVED TO CONTINUE BY USING A DESTINATION SLENDER 149CM SHEATH AS A REPLACEMENT TO CROSS. THE ISSUE WAS THE SEVERE IN-STENT RESTENOSIS (ISR) AND SMALL STENT DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587069 ↗
• InjuryDec 12, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS TREATING A PERIPHERAL ARTERIAL DISEASE (PAD) IN THE LEFT LEG, HE ACCESSED THE RIGHT FEMORAL ARTERY VIA ULTRASOUND AND A 5FR COOK MICRO-PUNCTURE KIT, THEN EXCHANGED IT FOR A 5FR 11 CM CORDIS SHEATH. NO RESISTANCE WAS MET. WITH A 260 CM STIFF ZIP WIRE AND A 65 CM OMNI CATHETER, HE NAVIGATED HIS WIRE OVER THE ILIAC BIFURCATION TO THE LEFT COMMON ILIAC AND DOWN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE DOCTOR THEN REMOVED HIS CATHETER AND THE 5FR CORDIS SHEATH TO EXCHANGE FOR A 6FR SHEATH STRAIGHT TO A PINNACLE DESTINATION SHEATH. AS HE TRIED TO ADVANCE THE SHEATH OVER THE WIRE INTO THE ACCESS SITE, RESISTANCE WAS MET AND STOPPED. IT WAS NOTED THAT THE TIP OF THE DESTINATION SHEATH SEEMED TO BE DAMAGED. A NEW DESTINATION SHEATH WAS OPENED AND INSERTED INTO THE ACCESS SITE WITH NO ISSUES. THE CASE WAS COMPLETED, AND SUCCESSFUL HEMOSTASIS WAS ACHIEVED USING AN ABBOTT PERCLOSE DEVICE. THE PATIENT WAS IN STABLE CONDITION. THE OUTCOME OF THE PROCEDURE WAS SUCCESSFUL. THE BLOOD LOSS WAS LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 16NOVEMBER2020: THE TYPE OF DAMAGE THAT WAS NOTICED ON THE DEVICE WAS A FISH MOUTH AT THE TIP OF S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10994868 ↗
• MalfunctionSep 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED AFTER INSPECTING ALL OF THEIR STOCK ON HAND, THE DESTINATION SHEATH WAS FOUND TO HAVE A CCV LOOSE IN THE PACKAGING. THE PACKAGE REMAINED STERILE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7910787 ↗
• MalfunctionSep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED WHEN THE DESTINATION PACKAGE WAS OPENED, THE CCV FELL OUT OF THE PACKAGE AND ON TO THE FLOOR. THE CCV AND SHEATH WERE NOT SCREWED TOGETHER. THE PRODUCT NEVER TOUCHED THE PATIENT, HOWEVER THE PRODUCT WAS OPENED AND REMAINED CLEAN. THE PROCEDURE OUTCOME WAS SUCCESSFUL, AND THE PATIENT CONDITION WAS GOOD. THERE WERE NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT. A SECOND SHEATH WAS OPENED. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 18, 2018. THE PROCEDURE WAS A LOWER EXTREMITY ANGIOGRAM AND INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905764 ↗
• MalfunctionApr 27, 2017Break; Break

  THE USER FACILITY REPORTED THE VALVE WAS DISCONNECTED WHEN THE DESTINATION PACKAGE WAS OPENED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED: ATTEMPTED TO SCREW VALVE DOWN BUT WOULD NOT "LOCK"; A SECOND UNIT WAS OPENED AND USED; WHEN THE PHYSICIAN REMOVED A CATHETER THROUGH THE VALVE THE VALVE "POPPED OFF"; THE PROCEDURE WAS SUCCESSFUL; AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 4/6/2017: BLOOD LOSS WAS MINIMAL AS THEY WERE ABLE TO SECURE THE VALVE IMMEDIATELY.

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

  MAUDE report 6525844 ↗
• MalfunctionApr 27, 2017Connection Problem; Connection Problem

  THE USER FACILITY REPORTED THE VALVE WAS DISCONNECTED WHEN THE DESTINATION PACKAGE WAS OPENED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED: ATTEMPTED TO SCREW VALVE DOWN BUT WOULD NOT "LOCK"; A SECOND UNIT WAS OPENED AND USED; WHEN THE PHYSICIAN REMOVED A CATHETER THROUGH THE VALVE THE VALVE "POPPED OFF"; THE PROCEDURE WAS SUCCESSFUL; AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525834 ↗