NanoCross™ Elite AB14W050100150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000110307), received between Apr 24, 2019 and Mar 14, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 14, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  A PHYSICIAN ATTEMPTED TO USE TWO NANOCROSS BALLOONS DURING TREATMENT OF CALCIFIED LESIONS WITH CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE TIBIAL/POPLITEAL TRUNK (TPT). THE DIAMETER OF THE SFA WAS 5MM AND THE TPT WAS 3MM. THE LENGTH OF THE LESION WAS 20-40MM. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS MODERATE. A 6FR NON MEDTRONIC SHEATH AND A NITRIX GUIDEWIRE WERE USED. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOONS WERE INFLATED USING A NON MEDTRONIC DEVICE WITH HEP SALINE 60/CONTRAST 40. IT WAS REPORTED THE PHYSICIAN INITIALLY USED A 3MM BALLOON TO PRE DILATE THE CHRONIC TOTAL OCCLUSION IN THE SFA. HAWKPLUS M WAS USED SUCCESSFULLY. PHYSICIAN ATTEMPTED TO INFLATE A 5MM NANOCROSS BALLOON AND IT RUPTURED AT 8 ATM DURING THE INITIAL INFLATION AND WAS REMOVED INTACT. THEN ATTEMPTED TO INFLATE A 3MM BALLOON IN THE TPT UNSUCCESSFULLY, IT DID NOT REGISTER PRESSURE AND HAD ONE INFLATION AT 8 ATM FOR TWO MINUTES AND WAS REMOVED INTACT. THEY THEN USED 2.5-100 NANOCROSS SUCCESSFULLY IN TPT AND DEPLOYED AN ENTRUST STENT. THE SFA WAS POST DILATED WITH A NANOCROSS AT 8 ATM FOR 2 MINS. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535931 ↗
• MalfunctionNov 24, 2022Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  A NANOCROSS ELITE PTA BALLOON CATHETER WAS BEING USED FOR THE TREATMENT OF AN UNKNOWN LESION IN THE POPLITEAL ARTERY. THE BALLOON WAS INFLATED USING THE EVEREST INFLATION DEVICE. IT WAS REPORTED THE BALLOON RUPTURED/LEAKED AT 8ATM. THE PROCEDURE ENDED AFTER THE EVENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859968 ↗
• MalfunctionMay 10, 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 RIGHT MID POPLITEAL ARTERYLESION IN A PATIENT THAT¿S FIBROUS WITH 70% STENOSIS AND LITTLE CALCIFICATION. A 0.014 NON MEDTRONIC WIRE WAS USED WITH A NON-MEDTRONIC 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 OCCURRED DURING INFLATION AT 4ATMS, THE BALLOON WAS INFLATED 4 TIMES IN THE SAME AREA WITH NO ISSUES, RUPTURE OCCURRED AT 5TH INFLATION. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH AA NEW BALLOON. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798354 ↗
• InjuryApr 24, 2019Deflation Problem; Deflation Problem

  THE PHYSICIAN WAS INTENDING TO USE A NANOCROSS ELITE TO TREAT A 100MM CALCIFIED PLAQUE LESION WITH 90% STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER OF 5MM. A 7FR NON-MEDTRONIC SHEATH AND A 5MM SPIDERFX WAS USED IN THE PROCEDURE. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND EXCESSIVE FORCE WAS NOT USED. THE BALLOON WAS INITIALLY INFLATED USING A NON MEDTRONIC INFLATION DEVICE WITH ISOVUE 370 HEPARINIZED SALINE FLUID. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON WAS DEFLATED USING A WIRE PUNCTURE TECHNIQUE THROUGH THE BALLOON LUMEN. THE DEFLATED BALLOON WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8543480 ↗

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,