NanoCross™ Elite AB14W025210150 (UDI 00763000757540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000757540), received between Aug 6, 2024 and Feb 25, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE DISTAL RIGHT PEDAL ARTERY, A BALLOON TWIST WAS OBSERVED. A REWRAP TOOL WAS NOT USED. A REWRAP ISSUE WAS NOT NOTED. A 7FR SHEATH AND A 0.014 GUIDEWIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH FIRST INFLATION, BUT THE BALLOON COULD NOT FULLY INFLATE DURING SECOND INFLATION. A REPLACEMENT NON-MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440067 ↗
• MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DEVICE FOR PATIENT TREATMENT IN THE PERONEAL ARTERY. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THERE WAS A BALLOON TWIST NOTED DURING THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738056 ↗
• MalfunctionMay 9, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON, A BALLOON BURST OCCURRED DURING FIRST INFLATION IN THE PERIPHERAL ARTERY, SPECIFICALLY THE POSTERIOR TIBIAL ARTERY. THE TARGET LESION WAS CALCIFIED, AND THE BURST WAS NOTED TO BE CIRCUMFERENTIAL/RADIAL DURING THE PROCEDURE. THERE WAS DIFFICULTY IN REMOVING THE BALLOON CATHETER AS IT CAUGHT UPON THE SHEATH DURING WITHDRAWAL. THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT INJURY OR INTERVENTION, AND THE PROCEDURE WAS COMPLETED USING A NEW NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994185 ↗
• MalfunctionJan 30, 2025Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE PROXIMAL/MID REGION OF THE RIGHT ANTERIOR TIBIAL ARTERY USING A NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON, THE BALLOON BURST. THE LESION WAS CHARACTERIZED BY 70-100% STENOSIS, A LENGTH OF 200MM, AN ARTERY DIAMETER OF 2-3MM, MODERATE TORTUOSITY, AND SEVERE CALCIFICATION. THE BALLOON WAS INFLATED USING A NON MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID. DURING THE FIRST INFLATION, THE BALLOON BURST AT 14ATM, NOTED AS A PINHOLE TYPE BURST. NO BALLOON ATTACHMENT OCCURRED. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT IT WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272652 ↗
• InjuryAug 6, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 90CM 6FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENTS RIGHT PROXIMAL ANTERIOR TIBIAL ARTERY. MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 95% STENOSIS. ARTERY DIAMETER REPORTED AS 3MM. 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 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 DURING PROCEDURE. ISSUE OCCURRED ON FIRST INFLATION AT 3ATMS. THE BALLOON DETACHED AT THE TARGET LESION. A SNARE WAS USED TO R EMOVE THE DETACHED PIECES/FRAGMENTS OF THE BALLOON. PROCEDURE WAS ABORTED. NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918983 ↗

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,