NanoCross™ Elite AB14W030210150 (UDI 00763000757700)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000757700), received between Jan 22, 2025 and Mar 5, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 DEVICE TO TREAT PERIPHERAL ARTERY PLAQUE IN THE RIGHT MID POSTERIOR TIBIAL ARTERY (70% STENOSIS, 250 MM LESION LENGTH, 3 MM ARTERY DIAMETER, MODERATE CALCIFICATION, MINIMAL TORTUOSITY), THERE WERE DELAYS IN SURGERY OF FIVE MINUTES DUE TO PRODUCT MALFUNCTION. DEFLATION DIFFICULTIES WERE ENCOUNTERED, AS THE BALLOON COULD NOT BE FULLY DEFLATED FOR REMOVAL. THE BALLOON DETACHED WITHIN THE SHEATH, AND CATHETER TOLERANCE WAS DEGRADED. THE SHEATH USED WAS A 6FR DESTINATION, AND THE GUIDEWIRE WAS A .014 GLADIUS. THE VESSEL WAS POST-DILATED WITH A NANO 3-2.5 DEVICE, AND INFLATION WAS PERFORMED WITH A PROGRAMMER 26 USING A 70 SALINE/30 CON FLUID. NEGATIVE PRESSURE AND PULLING WERE APPLIED TO DEFLATE THE BALLOON. THE DETACHED BALLOON COMPONENT WAS REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY REMOVING EVERYTHING WITH THE WIRE IN PLACE AND A NEW SHEATH TO FINISH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517131 ↗
• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 BALLOON, A CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF THE DISTAL TIBIAL/POPLIETAL TRUNK WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION WAS PRESENT. DURING BALLOON INFLATION, THE BALLOON BURST AND A CATHETER LEAK OCCURRED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE. NO EMBOLIC PROTECTION WAS USED, AND NO RESISTANCE OR EXCESSIVE FORCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931727 ↗
• MalfunctionFeb 7, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING A NANOCROSS BALLOON, THERE WERE PROCEDURAL ISSUES RELATED TO THE DEFLATION OF THE BALLOON. THE BALLOON DID NOT DEFLATE AT THE TYPICAL RATE, REQUIRING MULTIPLE ATTEMPTS AND TAKING SEVERAL MINUTES TO DEFLATE. NEGATIVE PRESSURE WAS APPLIED TO AID IN THE DEFLATION PROCESS. DUE TO THE EXTENDED TIME REQUIRED TO WITHDRAW THE DEVICE, A NEW NANOCROSS BALLOON WAS USED. THE NEW BALLOON WAS INSPECTED, PREPPED, AND INFLATED WITHOUT FURTHER ISSUES. THE LESION LENGTH WAS SPECIFIED AS 150 MILLIMETERS, AND THE PROCEDURE WAS COMPLETED USING THE NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332804 ↗
• InjuryJan 22, 2025Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE NANOCROSS 014 BALLOON DILATATION DEVICE FOR PATIENT TREATMENT. A NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE AND A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER IFU HOWEVER ISSUES OCCURRED PREPPING THE DEVICE AND FLUSHING. IT WAS REPORTED THAT DEFLATION DIFFICULTIES ISSUES OCCURRED, AND DEVICE TOOK 5 MINS TO DEFLATE USING NEGATIVE PRESSURE WITH A 20ML SYRINGE WHICH CAUSED THE BALLOON TO DETACH IN THE VESSEL. THE DETACHED BALLOON WAS SNARED AND REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO FURTHER PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206319 ↗

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,