NanoCross™ Elite AB14W060120150 (UDI 00763000110482)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000110482), received between Apr 27, 2020 and Nov 24, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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.

• MalfunctionNov 24, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON CATHETER FOR THE TREATMENT OF AN UNKNOWN LESION IN THE PROXIMAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING THE EVEREST INFLATION DEVICE. IT WAS REPORTED THE BALLOON DETACHED FROM THE CATHETER WHEN BEING REMOVED THROUGH THE SHEATH. THE BALLOON WAS ALMOST STUCK IN THE SHEATH.  THE WHOLE SHEATH WAS REMOVED AND CLOSURE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859991 ↗
• MalfunctionSep 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED A NANOCROSS BALLOON BURST BEFORE 14ATM DURING AN ANGIOPLASTY PROCEDURE TO TREAT PATIENTS POPLITEAL ARTERY.NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER THE IFU. DEVICE WAS INFLATED WITH AN EVEREST ENDOFLATOR. HALF AND HALF CONTRAST AND HEP SALINE INFLATION FLUID USED. NO EMBOLIC PROTECTION USED. ISSUE OCCURRED ON FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PTA. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL TREATMENT REQUIRED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453595 ↗
• MalfunctionSep 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED A NANOCROSS BALLOON BURST BEFORE 14ATM DURING AN ANGIOPLASTY PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER THE IFU. DEVICE WAS INFLATED WITH AN EVEREST ENDOFLATOR. HALF AND HALF CONTRAST AND HEP SALINE INFLATION FLUID USED. NO EMBOLIC PROTECTION USED. ISSUE OCCURRED ON FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PTA. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL TREATMENT REQUIRED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453589 ↗
• InjuryMay 31, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON CATHETER TO TREAT A PROX/MID SUPERFICIAL FEMORAL ARTERY LESION IN THE IN A PATIENT WITH PLAQUE, LITTLE TORTUOSITY, AND MODERATE CALCIFICATION. A NON-MEDTRONIC INFLATION DEVICE AND A NON-MEDTRONIC GUIDEWIRE WAS USED. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DAMAGE NOTED TO PACKAGING. DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. A STENT WAS PLACED IN THE SFA. A 6X120 NANOCROSS BALLOON WAS INFLATED TO POST DILATE THE STENT. THE PHYSICIAN WENT TO 16ATM, WHICH IS PAST RBP AND THE BALLOON BURST. WHEN TRYING TO RETRIEVE THE BURST BALLOON, THE BALLOON MUST HAVE GOT CAUGHT ON SOMETHING AND THE BALLOON PORTION PEELED OFF OF THE CATHETER, AND THE DISTAL END OF THE CATHETER SNAPPED OFF. THE PORTION OF THE BALLOON THAT GOT STUCK IN THE STENT WAS UNABLE TO BE RETRIEVED. THE PHYSICIAN COULD NOT ADVANCE A WIRE PAST THE BALLOON WHEN IT CAME OFF OF THE CATHET

  Patient problems: Obstruction/Occlusion

  MAUDE report 14546062 ↗
• MalfunctionJan 4, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE WITH A NON-MEDTRONIC SHEATH AND SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 120MM FIBROUS LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. 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. AN INFLATION DEVICE WITH 50/50 SALINE AND CONTRAST MIX WAS USED FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. AN INFLATION ISSUE HAS BEEN REPORTED. IT IS REPORTED THE CANDY-WRAPPER TYPE EFFECT (BALLOON TWIST) IN THE BALLOON WHERE THE BALLOON WILL NOT INFLATE FULLY OR AT ALL OCCURRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11107992 ↗
• InjuryApr 27, 2020Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 14ATM IN A VERY CALCIFIED SFA PTA BYPASS GRAFT. AS THE DEVICE WAS BEING REMOVED IT WAS SUSPECTED THE BALLOON COULD NOT FULLY DEFLATE. THE BALLOON WAS REPORTED TO BE STUCK ON THE WIRE SO A NON-MEDTRONIC DEVICE WAS ADVANCED OVER THE BALLOON. A NEEDLE WAS INSERTED TO THE BALLOON TO FULLY DEFLATE THE PROXIMAL PORTION. A GOOSENECK SNARE DEVICE WAS THEN ADVANCED TO REMOVE THE FRAGMENTED PORTIONS. ALL BALLOON FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000157 ↗

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,