NanoCross™ Elite AB14W040080150 (UDI 00763000757946)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000757946), received between Feb 18, 2025 and Mar 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141118); they may or may not involve this specific model.

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.

• MalfunctionMar 5, 2026Deflation Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING THE NANOCROSS 014 BALLOON CATHETER IN THE LEFT SUPERFICIAL FEMORAL ARTERY (MID AND DISTAL SEGMENTS) OF A PATIENT WITH, SEVERE CALCIFICATION AND A CHRONIC TOTAL OCCLUSION IN A SHORT SEGMENT WITH 80-90% STENOSIS IN THE REMAINING SEGMENT WERE PRESENT. THE LESION MEASURED 120 MM IN LENGTH WITH A VESSEL DIAMETER OF 5 MM. MINIMAL RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE VESSEL WAS PRE-DILATED WITH A NANO 4/80 DEVICE. DEFLATION DIFFICULTIES WERE NOTED WITH THE BALLOON CATHETER; THE BALLOON WAS INFLATED TO 18 ATM AND THEN RAPIDLY DEFLATED TO 4 ATM, WITH NO CONTRAST OBSERVED IN THE INFLATOR. THE BALLOON REQUIRED MULTIPLE INFLATIONS AND DEFLATIONS WITH SALINE TO THIN THE CONTRAST MIX, AND THE BALLOON AND SHEATH WERE EVENTUALLY PULLED OUT OF THE BODY AFTER APPROXIMATELY 10 MINUTES. THE BALLOON WAS INFLATED WITH WHAT THEY BELIEVE TO BE A 70/30 CONTRAST TO SALINE MIX. BECAUSE THE CONTRAST AMOUNT WAS TOO MUCH IT IS BELIEVED THAT THIS CAUSED THE ISSUE WITH DEFLATION. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORT ED AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519505 ↗
• MalfunctionFeb 18, 2025Burst Container or Vessel; Device Damaged by Another Device; Burst Container or Vessel; Device Damaged by Another Device

  IT WAS REPORTED THAT A PATIENT HAS HISTORY OF 2¿3-MONTH-OLD LIMFLOW STENT GRAFT ARTERIALIZATION FROM TPT ARTERY TO DISTAL POSTERIOR TIBIAL VEIN. THE PATIENT RECEIVED OVERNIGHT LYSIS OF THE LIMFLOW AND WAS BROUGHT BACK TO THE ANGIO SUITE FOR INTERVENTION. THE DISTAL END OF THE STENT GRAFT HAD A TIGHT STENOTIC LESION THAT WAS CROSSED WITH AN .014 VIPERWIRE. DURING THE PROCEDURE, A NANOCROSS 014 BALLOON WAS ADVANCED ACROSS THE LESION AND INFLATED TO RATED BURST PRESSURE, HOWEVER, THE BALLOON CIRCUMFERENTIAL/RADIAL RUPTURED AT 14 ATM DURING THE FIRST INFLATION AND ALLEGEDLY MAY HAVE GOTTEN SNAGGED ON THE LIMFLOW STRUTS AS IT WAS BEING RETRACTED. LEFT REMNANTS IN THE PATIENT. THE BALLOON DETACHED AND A PORTION OF THE DEVICE REMAINS IN THE PATIENT. THE PROCEDURE WAS ABORTED. DESPITE THESE ISSUES, THERE WERE NO COMPLICATIONS OR DAMAGE TO THE VESSEL PATENCY TO THE FOOT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399918 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141118. One submission often covers many models, so check the product and lot details in each record.

• Z-0904-2025 · Dec 10, 2024 · Open, Classified
  Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090,