NanoCross™ Elite AB14W050060150 (UDI 00763000110260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000110260), received between Dec 8, 2020 and Mar 23, 2021 — 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 23, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON DEVICE TO TREAT A LEFT MID SUPERFICIAL FEMORAL ARTERY LESION IN A PATIENT WITH PLAQUE WITH 80% STENOSIS AND LITTLE TORTUOSITY AND CALCIFICATION. A 0.014 NITREX WIRE WAS USED WITH A NON-MEDTRONIC 6FR SHEATH AND NON-MEDTRONIC INFLATION DEVICE. 50/50 INFLATION FLUID WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT THE BALLOON BURST AT 14ATMS, BALLOONING POST STENT. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A NON-MEDTRONIC BALLOON. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552607 ↗
• MalfunctionFeb 1, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR 45CM SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID POPLITEAL ARTERY WITH 90% STENOSIS. THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 60MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. SEVERAL ATTEMPTS WERE MADE OVER 2 MINUTES. THE DEFLATION ISSUE WAS NOTED FOLLOWING FIRST INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON WOULD NOT DEFLATE WHEN INDEFLATOR WAS PULLED NEGATIVE. AFTER SEVERAL ATTEMPTS PULLING NEGATIVE AND USING A SYRINGE TO PULL NEGATIVE, THE BALLOON DEFLATED AND WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257489 ↗
• InjuryDec 18, 2020Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON ALONG WITH 7FR SHEATH AND NON-MEDTRONIC 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 80MM RESPECTIVELY. A NON-MEDTRONIC INDEFLATOR WAS USED FOR BALLOON INFLATION. A 50/50 SALINE AND CONTRAST USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON DEFLATION DIFFICULTIES OCCURRED; THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE DEFLATION ISSUE WAS NOTED DURING SUBSEQUENT INFLATION AND THEN THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING INFLATION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON WAS INFLATED TO 8 ATM FOR PROCEDURAL PURPOSES. THE PHYSICIAN ALSO ATTEMPTED TO INFLATE THE BALLOON BEYOND THE RATED BURST PRESSURE IN AN ATTEMPT TO RUPTURE THE BALLOON AND REMOVE IT FROM THE PATIENT. THE PHYSICIAN DOESN¿T REMEMBER THE EXACT AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036247 ↗
• MalfunctionDec 8, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) LOCATED A MID, RIGHT FEM/POP STENT GRAFT. SEVERE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY IS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. DEFLATION DIFFICULTIES ARE NOTED. IT IS REPORTED THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE AND REMOVAL DIFFICULTIES WERE EXPERIENCED. THE BALLOON WAS FINALLY REMOVED AFTER 4 ATTEMPTS AT PULLING NEGATIVE PRESSURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10967330 ↗

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,