NanoCross™ Elite AB14W050120150 (UDI 00763000110321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000110321), received between Jan 6, 2020 and Mar 20, 2024 — classified as 2 injuries, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A LESION IN THE PATIENT¿S POPLITEAL ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. INFLATION DIFFICULTIES WERE REPORTED. NO LEAKS WERE NOTED ON THE DEVICE. DEFLATION DIFFICULTIES WERE ALSO REPORTED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL. THE CUSTOMER STATED THAT THE BALLOON TOOK A LOT LONGER THAN USUAL TO INFLATE AND DEFLATE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943680 ↗
• InjuryNov 15, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NANOCROSS TO TREAT A PLAQUE LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS 80%. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THERE WERE REMOVAL DIFFICULTIES FOLLOWING BALLOON INFLATION. A SECOND BALLOON, OF UNKNOWN MAKE OR MODEL, WAS USED TO ASSIST IN DEFLATING THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138174 ↗
• InjuryOct 3, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON DILATATION CATHETER AND SPIDER FX DEVICE FOR TREATMENT OF A 100MM CALCIFIED LESION WITH 89% STENOSIS IN THE PROXIMAL/MID REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 5MM IN DIAMETER WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE BALLOON WAS INFLATED USING A MEDTRONIC INFLATION DEVICE. THE NANOCROSS AND SPIDER FX WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED A CIRCUMFERENTIAL/RADIAL BURST OCCURRED DURING THE THIRD INFLATION AT 8ATM. AT THIS TIME THE BALLOON DETACHED FROM THE BALLOON CATHETER. THE PHYSICIAN ATTEMPTED SEVERAL TECHNIQUES TO REMOVE THE BALLOONMATERIAL AND FILTER WIRE BUT WAS NOT SUCCESSFUL. THE PHYSICIAN PULLED THE EMBOLIZED BALLOON MATERIAL, ALONG WITH THE FILTER BASKET, BACK TOWARD THE CONTRALATERAL COMMON FEMORAL ACCESS POINT, SO THAT THE SURGEON COULD PERFORM A SURGICAL CUTDOWN TO REMOVE THE BALLOON MATERIAL AND SPIDERFX FILTER BASKET AND WIRE. THE PATIENT WAS TRANSFERRED TO HOSPITAL FOR SURGICAL CUTDOWN TO REMOVE BALLOON MATERIAL AND FILTER BASKET. THE DEVICE DID NOT PASSTHROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED, NO EXCESSIVE FORCE WAS USED. NO FURTHER

  Patient problems: Insufficient Information

  MAUDE report 15528361 ↗
• MalfunctionAug 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON DURING PROCEDURE. AN UNKNOWN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 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. IT WAS REPORTED THAT BEFORE SECOND BALLOON INFLATION DEVICE DETACHED, CRACKED OR FRACTURE OCCURRED. IT WAS NOTICED AFTER BALLOON HAD BEEN USED ONCE AND THEY WERE LOADING IT TO USE IT A SECOND TIME. THE DETACHED PORTION DID NOT REMAIN IN THE PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN USED A DIFFERENT BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264886 ↗
• MalfunctionMay 20, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A FIBROUS CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT'S PROXIMAL, MID, AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. ISR IS REPORTED. A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST TO SALINE WAS USED FOR INFLATION. 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 DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A LONGITUDINAL BALLOON BURST IS REPORTED AT 8ATM DURING BALLOON INFLATION. THERE WERE NO PRIOR INFLATIONS APPLIED TO BALLOON. THE BALLOON DID NOT FRAGMENT. NO VESSEL INJURY NOTED, BALLOON WAS INFLATED INSIDE STENT, STENT WAS NOT DAMAGED. THE PHYSICIAN PULLED A SECOND BALLOON AND COMPLETED THE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14451803 ↗
• MalfunctionMar 21, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE AND PACIFIC XTREME PTA BALLOON CATHETERS DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL POPLITEAL ARTERY (POP). THE VESSEL WAS A LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 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. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 8ATM. ALL FRAGMENTS OF THE NANOCROSS BALLOON WERE RETRIEVED. PHYSICIAN REPLACED WITH A PACIFIC XTREME AND SAME THING OCCURRED. BALLOON RUPTURE OCCURRED AT 8ATM. ALL FRAGMENTS OF THE PACIFIC XTREME BALLOON WERE ALSO RETRIEVED. PROCEDURE WAS COMPLETED AFTER SECOND BALLOON RUPTURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838698 ↗
• MalfunctionJan 6, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE DURING TREATMENT OF A LESION IN THE PATIENT¿S MID POPLITEAL ARTERY. A NON-MEDTRONIC INFLATION DEVICE WAS USED. IFU WAS FOLLOWED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN THE DEVICE WAS REMOVED FROM THE HOOP/TRAY. IT IS REPORTED THAT DURING PREPARATION THAT AIR COULD NOT BE PURGED. THE DEVICE WAS NOT USED IN THE PATIENT. A SECOND NANOCROSS ELITE WAS ATTEMPTED TO BE USED. IFU WAS FOLLOWED. IT IS REPORTED THE DEVICE WAS PREPPED WITHOUT ISSUE. A BALLOON BURST IS REPORTED TO HAVE OCCURRED AT A PRESSURE OF 2 ATM DURING USE IN THE PATIENT. A NON-MEDTRONIC PTA BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552205 ↗

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,