NanoCross™ Elite AB14W025210150 (UDI 00821684066362)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684066362), received between Jul 19, 2017 and Oct 24, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS USING A NANOCROSS ELITE PTA BALLOON TO TREAT A SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL COMMON ILIAC ARTERY LESION EXHIBITING CHRONIC TOTAL OCCLUSION. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE AND A 50/50 CONTRAST SALINE MIX. THE BALLOON WAS USED TO INFLATE THE SUBINTIMAL SPACE OF THE COMMON ILIAC / AORTA. NO ISSUES WERE NOTED INFLATING OR DEFLATING THE BALLOON. THE PHYSICIAN EXPERIENCED REMOVAL DIFFICULTIES. THE BALLOON WAS FLUSHED IN AN ATTEMPT TO LUBRICATE THE BALLOON WITH NO SUCCESS. THE BALLOON DID NOT CATCH ON THE SHEATH DURING REMOVAL. THE PHYSICIAN WAS ABLE TO FORCEFULLY REMOVE THE BALLOON AND THE WIRE PLACEMENT WAS NOT LOST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6975138 ↗
• MalfunctionJul 19, 2017Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING, NOR ANY ISSUES IDENTIFIED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT MODERATE RESISTANCE WAS FELT DURING ADVANCEMENT. THE PHYSICIAN REPORTED THAT THE FIRST BALLOON WOULD NOT ADVANCE OVER THE WIRE PAST THE LESION, PERHAPS IT WAS TOO BIG, BUT DIFFICULTY WAS EXPERIENCED GETTING IT BACK OFF THE WIRE. THE LESION WAS THEN PRE-DILATED USING A 2MM BALLOON AND TRIED A DIFFERENT WIRE. THE BALLOON WAS STILL UNABLE TO CROSS, AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, THE DELIVERY CATHETER STRETCHED ENTIRELY AND TORE OFF ON THE WIRE. THE RADIO MARKERS DISLODGED IN THE SHEATH. THE PHYSICIAN THEN REMOVED ALL OF THE DEVICES AND ABORTED THE PROCEDURE. IT WAS REPORTED THAT NO COMPONENTS EMBOLIZED. NO PATIENT INFORMATION OF LESION MORPHOLOGY INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED. CONFIRMATION RECEIVED INDICATES THAT FOR THE FIRST BALLOON THE ALLEGATION IS THAT IT WOULD NOT CROSS. THE SECOND BALLOON HAD THE MARKERS DISLODGE IN THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6727256 ↗