NanoCross™ Elite AB14W050080150 (UDI 00763000110284)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000110284), received between Jan 6, 2020 and Jun 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Deflation Problem; Deflation Problem

  LIMITED INFORMATION REPORTED THAT THERE WERE DEFLATION DIFFICULTIES WITH THE NANOCROSS ELITE 5 MM X 80 MM X 150 CM BALLOON, SPECIFICALLY THAT THE BALLOON WOULD NOT DEFLATE PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210236 ↗
• MalfunctionOct 24, 2023Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER DURING TREATMENT OF A CALCIFIED LESION IN PATIENTS DISTAL POPLITEAL ARTERY. NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. EMBOLIC PROTECTION WAS USED. 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. A BALLOON BURST IS REPORTED DURING BALLOON INFLATION WHILE DILATING LESION. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. A DIFFERENT BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994829 ↗
• InjuryJan 6, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS USING NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT A NONE CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL RADIAL VEIN FISTULA WITH 80% STENOSIS. A NON MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT 6MM HG. THE BALLOON RUPTURED CIRCUMFERENTIALLY AND WINDSOCKED UPON REMOVAL AND DETACHED. A SNARE WAS USED TO RETRIEVE THE BALLOON FRAGMENTS AND CLOSED THE VEIN PUNCTURE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO FURTHER PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: Injury

  MAUDE report 9553540 ↗

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,