NanoCross™ Elite AB14W020210150 (UDI 00763000109561)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000109561), received between Feb 8, 2022 and Jan 23, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING THE ANTERIOR TIBIAL ARTERY AT THE DISTAL LOCATION WITH A CALCIFIED TARGET LESION, THE NANOCROSS 014 BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE DURING INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. SUBSEQUENTLY, A NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON WAS USED, BUT THE BALLOON DID NOT EXPAND SUFFICIENTLY, RESULTING IN BALLOON INFLATION DIFFICULTIES DURING INFLATION. BOTH DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED, AND NO DAMAGE WAS NOTED TO THE PACKAGING OR DURING DEVICE REMOVAL. EMBOLIC PROTECTION WAS NOT USED, AND THE INFLATION DEVICE ID-40S WAS UTILIZED FOR BOTH BALLOONS. THE PROCEDURE WAS COMPLETED BY OPENING AND USING ANOTHER BALLOON. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161058 ↗
• MalfunctionMay 15, 2024Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING TREATMENT OF THE ANTERIOR TIBIAL ARTERY. IT WAS REPORTED THE BALLOON BURST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318019 ↗
• MalfunctionDec 15, 2023Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS DEVICE WITH A NON-MEDTRONIC 6FR (TERUMO) SHEATH DURING TREATMENT OF A 210 MM CALCIFIED LESION IN PATIENT'S LEFT DISTAL ANTERIOR TIBIAL ARTERY. THERE WAS A MODERATE DEGREE OF TORTUOSITY AND CALCIFICATION. LESION STENOSIS WAS 80%. EMBOLIC PROTECTION WAS NOT USED. BALLOON WAS INFLATED WITH INFLATION DEVICE . DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DEVICE WOULD NOT DEFLATE AT LESION SITE FOLLOWING FIRST INFLATION. NO ISSUES NOTED DURING INFLATION. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER THERE WAS DIFFICULTY REMOVING THE DEVICE FROM PATIENT FOLLOWING BALLOON INFLATION, USING INFLATION DEVICE THE BALLOON WAS NOT FULLY DEFLATED FOR REMOVAL. DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE BALLOON WAS REMOVED AND PROCEDURE WAS FINISHED AS NORMAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335041 ↗
• MalfunctionMay 23, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE USE A NANOCROSS TO TREAT A PLAQUE LESION IN THE MID POSTERIOR TIBIAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS LITTLE. NO EMBOLIC PROTECTION WAS USED.  GENOSS INFLATION DEVICE WAS 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. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT 14 ATM. BURST WAS CIRCUMFERENTIAL/RADIAL. ALL FRAGMENTS WERE RETRIEVED. PROCEDURE WAS COMPLETED BY USING SAME SIZE NANOCROSS BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983030 ↗
• MalfunctionMay 2, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON FOR THE TREATMENT OF A CALCIFIED/FIBROUS LESION WITH 80% STENOSIS IN THE A NTERIOR TIBIAL ARTERY. A 6FR SHEATH AND 0.014" NON MEDTRONIC GUIDEWIRE WERE USED AND A NON MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING DELIVERY THROUGH THE VESSEL THE GUIDEWIRE LOCKED UP. THE PHYSICIAN PULLED THE GUIDEWIRE FROM THE LUMEN WITH RESISTANCE. THE BALLOON WAS REMOVED WITH THE WIRE STUCK. A BREAK/FRACTURE OCCURRED ON THE CATHETER. THE BALLOON WAS REMOVED WITH WIRE STUCK. TWO MARKERS ON THE BALLOON LEFT IN THE PATIENT. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO PATIENT INJURY OR INTERVENTION REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852780 ↗
• MalfunctionMay 26, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON TO TREAT A LESION IN THE PATIENT¿S POSTERIOR TIBIAL ARTERY. IT WAS REPORTED THAT THE DURING DELIVERY THROUGH THE VESSEL, REMOVAL DIFFICULTIES WERE ENCOUNTERED, AND BALLOON DETACHMENT OCCURRED AFTER SEVERAL INFLATIONS, THE PORTION OF THE BALLOON THAT DETACHED WAS NOT ABLE TO BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. NO FURTHER PATIENT INJURY REPORT FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14510928 ↗
• MalfunctionFeb 8, 2022Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WERE 2MM AND 210MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR THE BALLOON INFLATION. A STANDARD MIX WAS 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 DURING BALLOON INFLATION A LONGITUDINAL BURST OCCURRED AT NOMINAL PRESSURE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE WITH EXCESSIVE FORCE USED DURING DELIVERY. PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478484 ↗

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,