NanoCross™ Elite AB14W035210150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000110048), received between Sep 12, 2019 and Apr 19, 2024 — 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.

• MalfunctionApr 19, 2024Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USING A NANOCROSS ELITE PTA BALLOON FOR TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL/MID REGION OF THE ANTERIOR TIBIAL ARTERY. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. 50/50 CONTRAST WAS USED FOR INFLATION FLUID. THE IFU WAS FOLLOWED. IT WAS REPORTED AT 8ATM THE BALLOON BURST DURING THE FIRST INFLATION. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS YSED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141958 ↗
• MalfunctionFeb 3, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA).THE VESSEL HAD NO TORTUOSITY AND EXHIBITED 80% STENOSIS. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THERE WAS A LONGITUDINAL BALLOON BURST DURING BALLOON INFLATION AT 10 ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW NANOCROSS 3.5X210 BALLOON USED TO COMPLETE DILATION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13439732 ↗
• MalfunctionNov 3, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DEFLATION ISSUES WHEN USING A NANOCROSS OTW PTA BALLOON CATHETER DURING A PROCEDURE. THE DEFLATION TIME WAS REPORTED TO BE SIGNIFICANTLY LONGER. INFLATION DEVICE USED WAS A NON-MEDTRONIC DEVICE. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743067 ↗
• InjuryFeb 8, 2021Burst 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

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT DISTAL ANTERIOR TIBIAL ARTERY (ATA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED. 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. WHEN TRYING TO REMOVE THE BALLOON THE TIP BROKE/FRACTURED. THE DETACHED PORTION IS NOT IN PATIENT. A SNARE WAS USED TO RETRIEVE THE DETACHED PORTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BALLOON WAS USED TO DILATE THE TRACT BETWEEN ARTERY AND VEIN (AV REVERSAL). THE BALLOON RUPTURED AND TIP OF BALLOON BROKE AND REMAINED IN THE BODY. PHYSICIAN WAS ABLE TO SNARE AND RETRIEVE TIP AFTER ATTEMPTING FOR ABOUT AN HOUR. PATIENT HAD NO RESIDUAL EFFECTS POST REMOVAL OF BALLOON TIP. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11293968 ↗
• MalfunctionSep 12, 2019Deflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Difficult to Remove; Material Twisted/Bent

  PHYSICIAN WAS USING A NANOCROSS PTA BALLOON WITH A NON MEDTRONIC 6FR SHEATH AND GUIDE WIRE TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL POSTERIOR TIBIAL ARTERY WITH A 65% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2.3MM AND 80MM RESPECTIVELY. THE VESSEL IS LITTLE TORTUOUS. THE CONTRACT AND SALINE WAS USED TO INFLATE THE DEVICE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE FLOW WAS IMPEDED IN VESSEL. THE DEFLATION ISSUE WAS NOTED DURING SUBSEQUENT INFLATION. THE BALLOON DELIVERY SYSTEM WAS DEFORMED - STRETCHING AND TWISTING. PHYSICIAN ALSO EXPERIENCED DIFFICULTY REMOVING THE DEVICE FOLLOWING THE BALLOON INFLATION. THE BALLOON WAS EVENTUALLY DEFLATED ENOUGH TO BE PULLED OUT WITH THE SHEATH. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9005850 ↗

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,