Zoom RDL Radial Access System, 103cm ICTC088103RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812212030566), received between Jul 15, 2024 and Jan 24, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A FEMALE PATIENT WAS ADMITTED FOR AN EMBOLIZATION OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH WEB INTRASACCULAR DEVICE. RIGHT ICA ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY USING A ZOOM RDL. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES RELATED TO THE ACCESS AND THE ZOOM RDL. THE ZOOM RDL WAS RETRACTED INTO THE RADIAL ARTERY BUT HAD TO WAIT 2-3 MINUTES FOR THE TEAM TO OBTAIN AND PREP A TR BAND (RADIAL CLOSURE DEVICE). AFTER PLACEMENT OF THE TR BAND, THE PHYSICIAN CONTINUED TO REMOVE THE ZOOM RDL BUT FELT RESISTANCE. HE PULLED THROUGH THE RESISTANCE. UPON REMOVAL, A SEGMENT OF THE RADIAL ARTERY WAS NOTED ON THE CATHETER SHAFT. THERE WAS NO BLEEDING AT THE SITE AND NO EVIDENCE OF A HEMATOMA FORMING. THE PATIENT WAS TAKEN TO THE ANGIO SUITE TO PERFORM HAND LIGATION. THE ARTERY HAD BEEN DAMAGED APPROXIMATELY 5 CM PROXIMAL TO THE RADIAL ACCESS SITE. THE PATIENT MADE A FULL RECOVERY WITH FULL FUNCTION OF THE HAND. THE PHYSICIAN NOTED THAT THE ESTIMATED INNER DIAMETER (ID) OF THE RADIAL ARTERY WAS LIKELY TOO SMALL FOR THE OUTSIDE DIAMETER (OD) OF THE ZOOM RDL. ADDITIONALLY, IT WAS NOTED PRIOR TO REMOVAL OF THE ZOOM RDL THAT THERE WAS A DELAY TO PREP AND APPLY A TR BAND. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229458 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 73-YEAR-OLD FEMALE PATIENT WAS ADMITTED FOR A BILATERAL MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE. ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY USING A ZOOM RDL AS A GUIDE CATHETER. THE RDL CATHETER WAS NAVIGATED SMOOTHLY TO THE RIGHT EXTERNAL CAROTID ARTERY WITHOUT ISSUE. AFTER SUCCESSFULLY TREATING THE RIGHT SIDE, THE RDL CATHETER WAS RETRACTED AND ADVANCED ACROSS THE AORTIC ARCH TO THE LEFT COMMON CAROTID AND THEN UP TO THE LEFT EXTERNAL CAROTID. DURING THIS ADVANCEMENT, RESISTANCE WAS FELT; HOWEVER, THE OPERATORS WERE NOT CONCERNED ABOUT VASOSPASM. SUCCESSFUL TREATMENT OF THE LEFT MMA WAS ACCOMPLISHED WITHOUT ANY ISSUES. UPON COMPLETION AND FINAL ANGIOGRAPHY, THE PHYSICIAN ATTEMPTED TO REMOVE THE RDL. THE CATHETER WAS RETRACTED UNTIL THE DISTAL TIP OF THE RDL WAS SEVERAL CENTIMETERS ABOVE THE RIGHT ELBOW. HOWEVER, IT COULD NOT BE REMOVED. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE RDL WITHOUT DAMAGING THE ARTERY, INCLUDING ADMINISTERING MORE VASODILATORS (VERAPAMIL), USING A BLOOD PRESSURE CUFF, AND A TRANSPARENT RADIAL ARTERY BAND; BUT THE RDL WOULD NOT RELEASE. THE PATIENT WAS TRANSPORTED TO SURGERY FOR REMOVAL OF THE RDL. THE ORTHOPEDIC SURGERY TEAM SUCCESSFULLY R

  Patient problems: Vasoconstriction

  MAUDE report 20173509 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WAS ADMITTED FOR A BILATERAL MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY USING A ZOOM 88 SUPPORT GUIDE CATHETER. THE RIGHT-SIDE EMBOLIZATION WAS COMPLETED SUCCESSFULLY WITH NO ISSUES. HOWEVER, WHILE ATTEMPTING TO TRACK THE CATHETER THROUGH THE AORTIC ARCH OVER TO THE LEFT COMMON CAROTID ARTERY, SIGNIFICANT RESISTANCE WAS FELT. THE ZOOM 88 SUPPORT GUIDE CATHETER WAS REMOVED, AND A ZOOM RDL WAS INTRODUCED USING THE RDL DILATOR OVER 0.035" GLIDEWIRE ADVANTAGE AND A NON-DISCLOSED THIRD PARTY SELECT CATHETER. UPON ATTEMPTING TO ADVANCE THE ZOOM RDL INTO THE ARCH ANATOMY, RESISTANCE WAS AGAIN FELT. THE TREATING PHYSICIAN ATTEMPTED TO REMOVE THE RDL BUT WAS UNSUCCESSFUL. IT WAS CONFIRMED THAT VASOSPASM OCCURRED, AND THE RADIAL ARTERY CLAMPED DOWN ON THE SHAFT OF THE RDL AT APPROXIMATELY 3-4 CM FROM THE RADIAL ACCESS SITE. VASODILATOR MEDICATIONS WERE ADMINISTERED AT THE BEGINNING OF THE CASE AS WELL AS TO RELIEVE THE VASOSPASM. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE CATHETER, THE TREATING PHYSICIAN CALLED IN FOR SURGICAL SUPPORT. MEANWHILE, THE PHYSICIAN USED FEMORAL ACCESS AND SUCCESSFULLY COMPLETED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19743044 ↗