NanoCross™ Elite AB14W030150150 (UDI 00763000109868)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000109868), received between Apr 9, 2020 and Feb 13, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionFeb 13, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS PROXIMAL MID DISTAL SUP ERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL TORTUOSITY AND LITTLE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED FOR BAL LOON 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 IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE BALLOON DETACHED FROM CATHETER WHEN PULLING PTA OUT POST INFLATION. DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION WAS ALSO REPORTED. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT. DEVICE WAS PULLED OUT AND PHYSICIAN REWIRED WITH NEW WIRE TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695066 ↗
• InjuryMay 11, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON FOR TREATMENT OF A CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL REGION OF THE SU PERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND SEVERE CALCIFICATION. A 6FR SHEATH AND A NON MEDTRONIC GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE PATIENT HAD A CUTDOWN WITH ANTEGRADE ACCESS, AFTER INFLATION OF BALLOON, BALLOON WAS DEFLATED AND BEGAN TO BE REMOVED. HEARD A LOUD CRACK AND IT WAS NOTICED THE BALLOON HAD BROKEN AWAY FROM THE CATHETER. PATIENT HAD A CUTDOWN ALREADY FOR AN ENDART. DETACHMENT OCCURRED UPON WITHDRAWAL INTO SHEATH, REMOVED SHEATH AND BALLOON CATHETER. BITS OF THE BALLOON REMAINED ON THE WIRE. USED FORCEPS TO REMOVE BITS FROM WIRE. EXCHANGED WIRE AND CONTINUED PROCEDURE. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911243 ↗
• MalfunctionApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE USING NANOCROSS PTA BALLOON CATHETER, THE BALLOON PEELED AWAY FROM THE CATHETER WHILE IN THE PATIENT. IT STAYED ATTACHED TO CATHETER SO REMOVED AS NORMAL. NOTHING WAS LEFT BEHIND IN PATIENT. BALLOON WAS INFLATED USING A NON MEDTRONIC INDEFLATOR. DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE USED WHILE ADVANCING THE DEVICE. PROCEDURE WAS COMPLETED AS NORMAL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943734 ↗

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,