NanoCross™ Elite AB14W030210150 (UDI 00821684066522)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684066522), received between Mar 8, 2017 and May 29, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AND ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER AND A NANOCROSS 0.14 OTW PTA DILATATION CATHETER TO TREAT A MODERATE CALCIFIED, MODERATE TORTUOSITY LESION EXHIBITING 100% CHRONIC TOTAL OCCLUSION IN THE MID RIGHT TIBIAL/POPLITEAL TRUNK. THE EUPHORA BALLOON WAS INSPECTED WITH NO ISSUES NOTED, NEGATIVE PREP WAS PERFORMED ON THE EUPHORA BALLOON WITH NO ISSUES. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED, EXCESSIVE FORCE WAS NOT USED. NO EMBOLIC PROTECTION WAS USED ON THE NANOCROSS 0.14 OTW. THERE WAS NO ISSUES NOTED REMOVING NANOCROSS 0.14 OTW FROM THE HOOP/TRAY. THE NANOCROSS 0.14 OTW WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. IT IS REPORTED THAT BOTH BALLOONS BURST/RUPTURED ON THE INITIAL INFLATION AT APPROX. 8ATM. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649718 ↗
• InjuryMar 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A NANOCROSS DEVICE WITH A 6FR SHEATH AND 0.014 GUIDEWIRE FOR THE TREATMENT OF A 250 MM MODERATELY CALCIFIED LESION IN THE DISTAL/MID RIGHT SUPERFICIAL FEMORAL ARTERY/POSTERIOR TIBIAL ARTERY OF DIAMETER 3.0 MM. LESION EXHIBITED 70% STENOSIS. VESSEL DESCRIBED AS BEING SLIGHTLY TORTUOUS. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE NOR WAS EXCESSIVE FORCE USED. AN INFLATION DEVICE WAS USED WITH SALINE AND CONTRAST FOR INFLATION. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THERE WERE DIFFICULTIES EXPERIENCED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON POST INFLATION. IT IS REPORTED THE CATHETER WAS REMOVED WITH A GOOSENECK SNARE BUT A PORTION OF THE BALLOON HAD TORN AWAY FROM THE CATHETER. THE PHYSICIAN SUCCESSFULLY PULLED THE BALLOON FRAGMENTS OUT OF THE POSTERIOR TIBIAL ARTERY INTO THE SUPERFICIAL FEMORAL ARTERY. HOWEVER, HE WAS UNABLE TO BE PULL THE BALLOON THROUGH THE SHEATH. THE PHYSICIAN DECIDED TO DEPLOY A STENT TO TACK THE BALLOON MATERIAL TO THE VESSEL WALL. FOLLOWING DEPLOYMENT OF THE STENT THERE WAS BRISK

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7377412 ↗
• InjuryNov 22, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON TO TREAT A 300 MM LESION WITH LITTLE CALCIFICATION IN THE DISTAL RIGHT ANTERIOR TIBIAL ARTERY. THE ARTERY WAS 3 MM IN DIAMETER AND HAD 60% STENOSIS. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.014" NON-MEDTRONIC GUIDEWIRE. THE NANOCROSS BALLOON WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS INFLATED USING 50/50 INFLATION FLUID. THE PHYSICIAN EXPERIENCED NO RESISTANCE ADVANCING THE DEVICE AND IT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT DURING REMOVAL OF THE BALLOON, THE INSIDE OF THE BALLOON (BLUE INNER LINING) BECAME STUCK ON WIRE AND WAS PULLED OUT LEAVING THE BALLOON WITH NO STIFFNESS BEHIND. THE BALLOON WAS REMOVED USING A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED USING ANOTHER NANOCROSS DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7051875 ↗
• MalfunctionMar 8, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN USED THE NANOCROSS 014 TO TREAT A HEAVILY CALCIFIED LONG LESION WITH 95% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED REMOVING THE BALLOON FOLLOWING BALLOON INFLATION AND RESISTANCE WAS ENCOUNTERED REMOVING THE CATHETER FROM THE PATIENT. THE CATHETER WAS PULLED BACK INTO THE SHEATH, IT WAS OBSERVED THAT THE BALLOON HAD DETACHED WITHIN THE SHEATH. THE SHEATH WAS REMOVED FLUSHED AND INSERTED BACK INTO THE PATIENT WITH NO ISSUES NOTED. THE PROCEDURE WAS COMPLETED WITHOUT INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6386730 ↗