NanoCross™ Elite AB14W060040150 (UDI 00763000110406)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000110406), received between Nov 12, 2019 and Jun 6, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER DURING TREATMENT OF A CALCIFIED LESION IN PATIENTS PROXIMAL ARTERY/VEIN. LESION EXHIBITED 75% STENOSIS. EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED BALLOON INFLATION DIFFICULTIES OCCURRED. A HOLE IN THE BALLOON IS REPORTED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS REMOVED SAFELY FROM THE PATIENT WITH NO INJURY. A REPLACEMENT BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071393 ↗
• MalfunctionAug 24, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS ELITE PTA BALLOON ALONG WITH A NON MEDTRONIC 6FR SHEATH AND 0.014" MEDTRONIC NITREX GUIDEWIRE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID RIGHT POPLITEAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY AND 85% STENOSIS. THE ARTERY DIAMETER WAS 6MM AND LESION LENGTH WAS 30MM. A NON MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE TO THE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON STARTED TO LEAK CONTRAST DURING INFLATION AND BURST AT 8ATM AFTER 1 INFLATION. IT WAS A PIN HOLE BURST. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON WAS REMOVED AND ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. ALL PARTS OF THE BALLOON WERE REMOVED AND NO VESSEL DAMAGE WAS SEEN DURING POST INFLATION ANGIO. THE DEVICE WAS REMOVED SAFELY WITHOUT ANY VESSEL DAMAGE. NO OTHER INTERVENTION WAS NEEDED TO REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED BY PLACING A 6 X40 EVERFLEX STENT AND USING AN EVERCROSS BALLOON, POST DILATION WAS DONE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358827 ↗
• InjuryJun 17, 2021Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION ON THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80-90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6-7MM AND 30MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. INFLATION DEVICE WAS USED FOR BALLOON INFLATION. HEP SALINE WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. DURING SINGLE INFLATION, BALLOON BURST OCCURRED AT 12ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. DURING WITHDRAWAL EXCESSIVE FORCE WAS USED. PHYSICIAN ABORTED CASE AFTER BALLOON REMAINED PARTIALLY IN THE BODY TO BE REMOVED. PATIENT WAS OK POST OP NO EVENTS RELATED TO THE PROCEDURE. IT WAS REPORTED THAT CONTRALATERAL ACCESS WAS USED WHEN TREATING A 80-90% STENOTIC RIGHT COMMON FEMORAL ARTERY USING ATHERECTOMY THX-

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12017124 ↗
• InjuryMay 11, 2021Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN USED A NANOCROSS ELITE PTA BALLOON AND SPIDER FX EMBOLIC PROTECTION DEVICE DURING PATIENT TREATMENT ON THE SFA FOR ATHERECTOMY AND PTA. A DISTAL SFA CTO WAS TREATED WITH DIRECTIONAL ATHERECTOMY OF THE NATIVE ARTERY AND A DCB WAS USED IN THE NATIVE ARTERY AND PREVIOUSLY PLACED STENT IN THE PROXIMAL SFA. THE NANOCROSS WAS THEN USED TO TREAT THE AREA OF THE STENT THAT STILL HAD A SMALL DEFECT IN ITS LUMEN. DURING THE PROCEDURE, THE BALLOON WAS OVER INFLATED BEYOND RECOMMENDED PRESSURE AND THE BALLOON RUPTURED ON THE FIRST INFLATION. THE NANOCROSS BALLOON WAS ON THE SPIDER WIRE DURING THE RUPTURE AND GOT STUCK IN THE SHEATH, MAKING IT IMPOSSIBLE TO CAPTURE AND REMOVE THE SPIDER. THE SPIDER WAS WITHDRAWN BACK TO THE COMMON FEMORAL ACCESS SITE ALONG WITH THE RUPTURED NANOCROSS, BUT WAS UNABLE TO BE REMOVED FROM THE BODY PERCUTANEOUSLY DUE TO THE NANOCROSS BEING STUCK AT THE ACCESS SITE. THE PATIENT WENT TO EMERGENCY SURGERY TO REMOVE THE BALLOON AND SPIDER FX. ALL COMPONENTS OF THE DEVICES WERE REMOVED VIA EMERGENCY SURGERY. THE PATIENT IS ALIVE AND NO COMPLICATIONS WERE REPORTED. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11804548 ↗
• MalfunctionAug 7, 2020Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND SPIDER FX 0.14 6MM GUIDE WIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED FIBROUS LESION IN THE RIGHT MID POPLITEAL ARTERY WITH 70% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 30MM RESPECTIVELY. A MEDTRONIC INFLATION DEVICE WAS USED FOR THE INFLATION OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. DURING BALLOON INFLATION, A PIN HOLE LEAK WAS NOTED AT 6ATM. IT WAS REPORTED THAT THE BALLOON WAS ADVANCED TO LESION IN POPLITEAL ARTERY OVER SPIDER FILTER WIRE AFTER ATHERECTOMY WITH TURBOHAWK SX-C WAS PERFORMED. AS BALLOON WAS BEING INFLATED AND WALL OF BALLOON WAS BEGINNING TO OPPOSE THE VESSEL WALL, CONTRAST WAS OBSERVED LEAKING FROM PROXIMAL END OF BALLOON. THE BALLOON WAS DEFLATED AND REMOVED. A NEW 5MM NANOCROSS WAS USED FOR POST DILATATION. THE VESSEL WAS CALCIFIED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378462 ↗
• MalfunctionNov 12, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS BALLOON CATHETER TO TREAT THE SFA. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING INFLATION, THE BALLOON BURST AT 8 ATM. THE ANGIOPLASTY WAS ACHIEVED WITH BALLOON PRIOR TO BURST. NO OTHER INTERVENTION TO FOLLOW. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310247 ↗

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,