NanoCross™ Elite AB14W060100150 (UDI 00763000110468)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000110468), received between May 10, 2022 and Aug 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2022Leak/Splash; Leak/Splash

  A PHYSICIAN WAS USING A NANOCROSS BALLOON TO TREAT THE LEFT SFA OF A PATIENT. NO TORTUOSITY REPORTED AND MODERATED CALCIFICATION. 50% LESION STENOSIS. A 6F SHEATH, 014 GUIDEWIRE AND NO EMBOLIC PROTECTION WERE USED. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE IFU WAS FOLLOWED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INSUFFLATOR. IT IS REPORTED THE BALLOON STARTED LEAKING FLUID AND IT DID NOT INFLATE AS HE NEED IT DURING USE. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO VESSEL DAMAGE DUE TO EVENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300182 ↗
• InjuryMay 10, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PATIENT UNDERWENT PROCEDURE FOR PRE-OPERATIVE DIAGNOSIS OF AN ABDOMINAL AORTIC ANEURYSM (AAA), LARGE 6.1CM. THE PROCEDURE PLAN WAS TO PLACE AN INFRARENAL GRAFT WITH FIXATION, POTENTIAL NEED FOR EXTENSION AND SNORKELING OF THE RENALS. THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL FASHION. USING TYPICAL TECHNIQUE AND ULTRASOUND GUIDANCE, AND AVOIDING THE PREVIOUS RECENT FEMORAL CANNULATIONS FOR TAVR, THE FEMORAL ARTERIES WERE IDENTIFIED AND CANNULATED USING ULTRASOUND GUIDANCE (USG) AND MICRO PUNCTURE TECHNIQUES. AFTER PASSING WIRES, THE PHYSICIAN SIZED UP TO 11FR SHEATHS. USING MULTIPLE CATHETERS, THE PHYSICIAN WAS ABLE TO GUIDE WIRES INTO THE THORACIC AORTA AVOIDING THE TAVR VALVE. A PIGTAIL CATHETER WAS PLACED IN THE SUPRARENAL LOCATION. THE NECK WAS VISUALIZED AS WELL AS THE LOWEST RENAL ARTERY. A GRAFT WAS PLACED FROM THE RIGHT. FOLLOWING PLACEMENT OF THE GRAFT, THE GRAFT JUNCTIONS WERE BALLOONED. FOLLOWING THIS PRIOR TO ANY OTHER FURTHER ANGIOGRAPHY WAS PERFORMED A FIXATION DEVICE WAS USED IN 7 LOCATIONS ON THE GRAFT TO WALL JUNCTION NEAR THE LEFT RENAL ARTERY LEVEL. CONTRAST ANGIOGRAPHY WAS THEN PERFORMED WITH A POWER INJECTOR, WITH ENDOLEAK VISIBLE. DESPITE MULTIPLE ATTEMPT

  Patient problems: Insufficient Information

  MAUDE report 14345217 ↗

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,