NanoCross™ Elite AB14W040150150 (UDI 00763000110185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000110185), received between Jan 22, 2020 and Oct 9, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 5FR NON-MEDTRONIC (COOK) SHEATH AND A .014 NON-MEDTRONIC (ASHAI GLADIUS) GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENTS LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS ILIAC BIFURCATION WITH SIGNIFICANT DISEASE AND CALCIFICATION MADE IT DIFFICULT TO TRACK SHEATH UP AND OVER. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST WAS REPORTED ON FIRST INFLATION AT 8ATMS DURING PROCEDURE. DEFLATION DIFFICULTIES WERE ALSO REPORTED. THE BALLOON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408330 ↗
• InjuryAug 8, 2024Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 5FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENTS LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS ILIAC BIFURCATION WITH SIGNIFICANT DISEASE AND CALCIFICATION MADE IT DIFFICULT TO TRACK SHEATH UP AND OVER. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST WAS REPORTED ON FIRST INFLATION AT 8ATMS DURING PROCEDURE. DEFLATION DIFFICULTIES WERE ALSO REPORTED. THE BALLOON WOULD NOT FULLY DEFLATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937511 ↗
• MalfunctionApr 19, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A NANOCROSS PTA BALLOON WAS USED FOR TREATMENT OF A LESION IN THE DISTAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE DURING ADVANCEMENT. IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVED FOLLOWING BALLOON INFLATION. THE BALLOON WAS FULLY DEFLATED AT THE TIME OF REMOVAL. THE BALLOON CATHETER GOT CAUGHT UPON THE SHEATH DURING WITHDRAWAL. BALLOON AND SHEATH WERE PULLED OUT AT THE SAME TIME. THERE WAS NO VESSEL DAMAGE AND DEVICE WAS SAFELY REMOVED FROM PATIENT. PROCEDURE COMPLETED WITH NO HARM TO PATIENT. WHEN THE DEVIEC WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE DEVICE WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141890 ↗
• InjurySep 29, 2022Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 7FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. CONTRAST AND SALINE WERE 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. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE 7 FRENCH 45CM COOK SHEATH WAS INSERTED INTO THE RIGHT COMMON FEMORAL ARTERY UP AND OVER THE AORTIC ARCH AND PLACED IN THE RIGHT DISTAL ILIAC ARTERY PROXIMAL TO THE COMMON FEMORAL ARTERY. THERE WAS A SIGNIFICANTSTENOSIS IN THE LEFT COMMON FEMORAL ARTERY WHICH PHYSICIAN INTENDED TO TREAT WITH DIRECTIONAL ATHERECTOMY. HOWEVER THE LEFT PROXIMAL SFA ARTERY H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504529 ↗
• MalfunctionApr 1, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE FIRST DEVICE. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST, LEAK OR RUPTURE OCCURRED AT AN UNKNOWN ATM. ANOTHER NANOCROSS PTA BALLOON WAS ATTEMPTED AND BALLOON BURST, LEAK OR RUPTURE OCCURRED AT AN UNKNOWN ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE BALLOONS WERE SAFELY REMOVED FROM PATIENT. THERE WAS NO VESSEL DAMAGE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977054 ↗
• InjuryOct 18, 2021Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON CATHETER ALONG WITH 6FR SHEATH, 0.014" AND SPIDER 5.0 EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA) WITH 70-80% STENOSIS. EVEREST INFLATION DEVICE WAS USED TO INFLATE BALLOON. 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. THERE WAS BALLOON DEFLATION DIFFICULTIES REPORTED, THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE VESSEL WAS PRE DILATED BUT NOT POST DILATED. THE SPIDER WAS UNABLE TO CROSS. IT WAS REPORTED THAT DURING ATTEMPT TO REMOVE FROM THE VESSEL, THE BALLOON DETACHED. DAMAGE WAS NOTED TO THE BALLOON CATHETER. THERE WAS NO ISSUE NOTED DURING INFLATION. THE DETACHED BALLOON WAS REMOVED VIA OPEN SURGERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN WENT IN WITH A 4.0X150 NANOCROSS, DID PTA ON PROXIMAL AND DISTAL SFA. AFTER THE 2ND INFLATION, THE BALLOON DID NOT FULLY DEFLATE. PHYSICIAN TRIED TO REMOVE THE BALLOON, BUT I

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12646928 ↗
• MalfunctionFeb 26, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A NANOCROSS 0.014 PTA BALLOON DURING TREATMENT OF THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). IT IS REPORTED THAT WHILE BALLOONING THE SFA THE BALLOON BURST AND STUCK TO WHAT APPEARED TO BE CALCIFICATION IN THE ARTERIAL WALL. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON. THE CATHETER WAS REMOVED WITHOUT THE BALLOON ATTACHED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756210 ↗
• MalfunctionJan 22, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS DEVICE WITH A 7F SHEATH AND A NON-MEDTRONIC GUIDE WIRE TO TREAT A CALCIFIED LESION IN A PATIENTS PROXIMAL SUPERFICIAL FEMORAL ARTERY AND DISTAL POPLITEAL ARTERY. LITTLE DEGREE OF TORTUOSITY AND SEVERE CALCIFICATION WERE REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. THERE WAS NO RESISTANCE FELT WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. DURING BALLOON INFLATION THE BALLOON BURST. 8 ATMS WAS APPLIED TO THE BALLOON PRIOR TO BURST. IT WAS REPORTED THAT THE TYPE OF BALLOON BURST WAS CIRCUMFERENTIAL/RADIAL. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PTA BALLOON. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9615504 ↗

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,