NanoCross™ Elite AB14W050200150 (UDI 00763000110369)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000110369), received between Oct 21, 2019 and Feb 7, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Burst 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

  IT WAS REPORTED THAT DURING A TRANSCATHETER ARTERIALIZATION OF DEEP VEINS (TADV) WITH AV CONNECTION PROCEDURE TO TREAT A 200MM CALCIFIED LESION IN THE MID RIGHT PERONEAL ARTERY USING A NANOCROSS ELITE BALLOON, THE BALLOON BURST AT 24 ATM, WHICH WAS ABOVE THE RATED BURST PRESSURE. THE BURST OCCURRED ON THE SECOND INFLATION. THE BURST WAS CIRCUMFERENTIAL/RADIAL, AND THE BALLOON DETACHED DURING THE EVENT. INTERVENTION WAS REQUIRED TO REMOVE THE BALLOON FRAGMENTS. THE BALLOON SHAFT AND PROXIMAL ONE-THIRD OF THE BALLOON WERE REMOVED THROUGH THE ANTEGRADE SHEATH, WHILE THE DISTAL TWO-THIRDS AND REMAINING SHAFT WERE REMOVED THROUGH A 6F SHEATH IN THE LATERAL PLANTAR VEIN. ARTERY DIAMETER REPORTED AS 5MM. A 7X45 NON-MEDTRONIC SHEATH AND A .014 NITREX GUIDEWIRE WERE USED. 50/50 CONTRAST INFLATION FLUID WAS USED. PHYSICIAN WAS ABLE TO MAINTAIN WIRE CONTROL (WIRE WAS FLOSSED). THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332014 ↗
• MalfunctionMar 13, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A 014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 180MM LESION IN THE PATIENT¿S MID POPLITEAL ARTERY. ARTERY DIAMETER WAS REPORTED AS 4.8MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. NO DAMAGE TO THE DEVICE REPORTED. NO ISSUES DURING INFLATION. BALLOON DEFLATION DIFFICULTIES WERE NOTED FOLLOWING FIRST INFLATION. THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE AND DEFLATION TOOK 800 SECONDS. PHYSICIAN USED A SYRINGE TO DEFLATE BALLOON. A REPLACEMENT NANOCROSS ELITE PTA BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18898808 ↗
• MalfunctionJan 16, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER DURING PATIENT TREATMENT. 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. A SYRINGE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED A BALLOON BURST OCCURRED DURING BALLOON INFLATION AT 12 ATMS DURING PRE-OP. DEVICE WAS NOT USED IN PATIENT. A REPLACEMENT NON-MEDTRONIC BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516037 ↗
• InjuryJun 13, 2022Deflation 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 ELITE PTA BALLOON ALONG WITH NON-MEDTRONIC 7FR SHEATH AND MULTIPLE "0.014 GUIDEWIRES INCLUDING NITREX AND A NON-MEDTRONIC ONE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED SOFT TISSUE LESION IN THE RIGHT PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS NONE TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. SALINE AND CONTRAST MIXTURE USED FOR INFLATION FLUID. 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. BALLOON DEFLATION DIFFICULTIES OCCURRED DURING REMOVAL. THE TIP, BALLOON AND CATHETER BROKE PULLING IT OUT. THERE WAS REMOVAL DIFFICULTIES NOTED FOLLOWING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON WAS INFLATED AND THEN COULD NOT BE FULLING DEFLATED AFTER MULTIPLE ATTEMPTS LEAVING IT UNABLE TO GET OUT OF PATIENT, THE PHYSICIAN FINALLY WAS ABLE SOMEHOW GET A SMALL ENOUGH HOLE IN THE BALLOON BY POKING

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 14673371 ↗
• MalfunctionJan 6, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS HAD LITTLE TORTUOSITY. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 200MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A 50/50 SALINE/CONTRAST WAS THE INFLATION FLUID USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPER PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON RUPTURE OCCURRED AT 14ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE RUPTURED BALLOON WAS REMOVED AND A 6X100 FORTREX AND 5X200 EVERCROSS PTA BALLOONS WERE USED TO DILATED THE DISTAL SFA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124177 ↗
• MalfunctionDec 29, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON ALONG WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80-90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 170MM RESPECTIVELY. MEDTRONIC EVEREST INFLATION DEVICE WAS USED. 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. NEGATOVE PREP WAS PERFORMED. THE BALLOON DID NOT INFLATE COMPLETELY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON WAS ADVANCED TO LESION. UPON INFLATION, PORTION OF THE BALLOON DID NOT EXPAND. PHYSICIAN SUSPECTED THAT THE SECTION UN-DEFLATED PORTION WAS POSSIBLY AN AIR BUBBLE. BALLOON WAS DEFLATED, REPOSITIONED AND RE INFLATED. SECTION OF BALLOON STILL DID NOT EXPAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087651 ↗
• InjuryDec 9, 2020Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 5MM. A 0.014 GUIDEWIRE WAS USED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT FOR POST DILATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION AT A PRESSURE OF 14ATM. IT IS REPORTED THE BALLOON COULD NOT DEFLATE. THE BALLOON COULD NOT DEFLATE, SO THE PHYSICIAN USED NEGATIVE PRESSURE. THE BALLOON TOOK 15 MINUTES TO DEFLATE, AS IT WAS A LONG AND TOUGH CTO AND THE DISTAL END GOT STUCK AND CAUGHT IN THE SHEATH. TWO ADDITIONAL NANOCROSS ELITE PTA BALLOONS WHICH WERE PREPPED AS PER IFU WERE ATTEMPTED TO BE USED BUT COULD NOT BE DEFLATED AT THE LESION SITE. ALL COMPONENTS OF ALL DEVICES WERE REMOVED FROM THE PATIENT WITH NO INTERVENTION REQUIRED. THE DEFLATION ISSUES ARE REPORTED TO HAVE CAUSED THROMBOSIS. NO FURTHER INJURY REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10974809 ↗
• InjuryDec 9, 2020Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 5MM. A 0.014 GUIDEWIRE WAS USED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT FOR POST DILATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION AT A PRESSURE OF 14ATM. IT IS REPORTED THE BALLOON COULD NOT DEFLATE. THE BALLOON COULD NOT DEFLATE, SO THE PHYSICIAN USED NEGATIVE PRESSURE. THE BALLOON TOOK 15 MINUTES TO DEFLATE, AS IT WAS A LONG AND TOUGH CTO AND THE DISTAL END GOT STUCK AND CAUGHT IN THE SHEATH. TWO ADDITIONAL NANOCROSS ELITE PTA BALLOONS WHICH WERE PREPPED AS PER IFU WERE ATTEMPTED TO BE USED BUT COULD NOT BE DEFLATED AT THE LESION SITE. ALL COMPONENTS OF ALL DEVICES WERE REMOVED FROM THE PATIENT WITH NO INTERVENTION REQUIRED. THE DEFLATION ISSUES ARE REPORTED TO HAVE CAUSED THROMBOSIS. NO FURTHER INJURY REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10974796 ↗
• InjuryNov 5, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION IS REPORTED. THERE WAS NO DAMAGE NOTED WHEN REMOVING THE DEVICE FROM THE PRODUCT PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. REMOVAL DIFFICULTIES ARE REPORTED. IT IS REPORTED AFTER INFLATION OF THE BALLOON TO 10ATM FOR 2 MINUTES, THE BALLOON WAS REPOSITIONED AND AGAIN INFLATED TO 10ATM. THE BALLOON IS REPORTED TO HAVE RUPTURED WITH THE BALLOON SHAFT STRIPPING OFF THE BALLOON. ON ATTEMPT TO REMOVE THE DEVICE, A SECTION OF THE BALLOON SEPARATED FROM THE CATHETER. ANTEGRADE ACCESS WAS GAINED AND A SNARE WAS USED TO RETRIEVE THE BALLOON IN THE POPLITEAL. THE PATIENT IS REPORTED TO BE FINE WITHOUT ANY REPORTED ISSUES. NO FURTHER INJURY RE PORTED.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10790980 ↗
• MalfunctionSep 8, 2020Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A 120MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION IS REPORTED. THE VESSEL IS DESCRIBED AS BEING NON-TORTUOUS. ARTERY DIAMETER REPORTED AS 5MM. LESION EXHIBITED 90% STENOSIS. NO DAMAGE WAS 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 WITH A 50/50 CONTRAST: SALINE MIX FOR BALLOON INFLATION. PRE-DILATION WAS SUCCESSFUL USING THIS DEVICE. AN EVERFLEX STENT WAS IMPLANTED AND THE NANOCROSS WAS RE-ADVANCED TO POST-DILATE THE STENT. NO RESISTANCE IS REPORTED DURING ADVANCEMENT. IT IS REPORTED THAT THE BALLOON BURST OCCURRED DURING INFLATION AT A PRESSURE OF 14ATM. 3 PRIOR INFLATIONS HAD BEEN APPLIED TO THE DEVICE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, THE PHYSICIAN COULD NOT REMOVE THE BALLOON THROUGH THE 6FR SHEATH AND REMOVED THE SHEATH WIRE AND BALLOON TOGETHER AS A UNIT. MANUAL PRESSURE WAS HELD AT THE PUNCTURE SITE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10500963 ↗
• MalfunctionOct 21, 2019Deflation Problem; Deflation Problem

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE WITH A 6FR NON-MEDTRONIC SHEATH AND 7MM SPIDER FX DEVICE DURING TREATMENT OF A 150MM FIBROUS LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. THE VESSEL IS DESCRIBED AS BEING NON-TORTUOUS AND SLIGHTLY CALCIFIED. LESION EXHIBITED 80% STENOSIS. PRE-DILATION WAS PERFORMED USING THE NANOCROSS ELITE. THE BALLOON WAS INFLATED WITH A CONTRAST/SALINE MIX USING A NON-MEDTRONIC INFLATION DEVICE. THE BALLOON WAS REMOVED AND A NON-MEDTRONIC STENT WAS PLACED. THE NANOCROSS BALLOON WAS REINSERTED TO POST-DILATE. THE BALLOON INFLATED AS NORMAL BUT WOULD NOT DEFLATE. AFTER MULTIPLE REINFLATIONS AND DEFLATIONS, AND UTILIZING A LARGE SYRINGE ON THE STOP COCK, THE BALLOON WAS DEFLATED SUCCESSFULLY AND REMOVED. TOTAL DEFLATION TIME REPORTED AS 240 SECONDS. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213339 ↗

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,