NanoCross™ Elite AB14W040210150 (UDI 00763000110208)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000110208), received between May 21, 2019 and Jun 3, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY NANOCROSS BALLOON, THERE WAS A DELAY IN SURGERY OF 10 MINUTES DUE TO DIFFICULTIES WITH BALLOON DEFLATION. THE BALLOON WOULD NOT DEFLATE AS INTENDED, RESULTING IN REMOVAL DIFFICULTIES. THE BALLOON WAS ULTIMATELY DEFLATED BY INTENTIONALLY PUNCTURING IT WITH A PUNCTURE WIRE TO FACILITATE REMOVAL. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22132909 ↗
• InjuryAug 23, 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 THE NANOCROSS PTA BALLOON ALONG WITH NON MEDTRONIC 7FR SHEATH DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL, MID AND DISTAL LOCATION OF THE SUPERFICIAL FEMORAL ARTERY(SFA), POPLITEAL ARTERY AND POSTERIOR TIBIAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY AND CHRONIC TOTAL OCCLUSION (CTO-100%).THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. IT WAS REPORTED THAT THE BALLOON BURST AT 6ATM DURING BALLOON INFLATION. THE TYPE OF BURST WAS CIRCUMFERENTIAL. THE BALLOON DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THERE WAS NO RESISTANCE OR EXCESSIVE FORCE USED. THE PROCEDURE WAS COMPLETED BY REMOVING THE SHEATH AND THE 2 MIDDLE MARKERS CAME OUT. THE SHEATH WAS PUT BACK IN BUT DISTAL END OF THE BALLOON WAS STILL MISSING. IT WAS SNARED AND IT GOT STUCK IN THE SHEATH SO A SNARE WIRE WAS USED TO REMOVE THE SHEATH. ALL FRAGMENT OF THE BALLOON WERE RETRIEVED. NO PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12352775 ↗
• MalfunctionMay 7, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA ALONG WITH A 7FR SHEATH, 0.014" SPIDER GUIDEWIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A 50% HEPARINIZED SALINE/50% OMNIPAQUE 350 WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON WAS DEFLATED VERY LITTLE AND PULLED THROUGH THE SHEATH. THE BALLOON WAS USED POST ATHERECTOMY AND WOULD NOT DEFLATE PROPERLY. PHYSICIAN PULLED BALLOON OUT THROUGH THE SHEATH STILL NOT COMPLETELY DEFLATED. A WHITE PIECE BETWEEN THE HUB AND CATHETER (PIECE THAT PROTECTS THE TRANSITION INTO HUB WAS NOT IN THE PROPER PLACE AND WAS DOWN THE SHAFT OF CATHETER UPON REMOVAL OUT OF LOOP). IT WAS MANUALLY PUSHED BACK INTO PLACE AND WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789218 ↗
• MalfunctionFeb 26, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESIONS IN THE RIGHT PROXIMAL TO DISTAL POPLITEAL, TIBIAL/POPLITEAL TRUNK AND POSTERIOR TIBIAL ARTERIES 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. DURING BALLOON FIRST INFLATION, IT RUPTURED AT 6ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. A NEW BALLOON WAS USED AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384914 ↗
• InjuryDec 8, 2020Burst Container or Vessel; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Burst Container or Vessel; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A NANOCROSS PTA BALLOON DURING TREATMENT OF A SOFT TISSUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL, RIGHT PLANTAR VEIN. MODERATE VESSEL TORTUOSITY IS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC (BARD) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED IN THE PEDAL VENOUS LOOP AFTER CREATING A SUCCESSFUL AV REVERSAL. IT IS REPORTED VEIN SPASM OCCURRED AND THE BALLOON BROKE OFF THE CATHETER. A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 6ATM DURING BALLOON INFLATION. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE BALLOON FRAGMENTS FROM THE PATIENT OVER 4 HOURS UNSUCCESSFULLY. VESSEL OCCLUSION DUE TO THE DEVICE COMPONENT IS REPORTED. THE VEIN IS REPORTED TO HAVE BEEN COILED. THE DETACHED PORTION REMAINS IN THE PATIENT. NO FURTHER INJURY REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 10967300 ↗
• MalfunctionOct 20, 2020Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN INTENDED TO USE A NANOCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID PERONEAL ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED DURING AN ATTEMPT TO REMOVE THE BALLOON FROM THE PATIENT, THE CATHETER IT WAS ON STRETCHED OUT AND THE BALLOON STAYED IN THE VESSEL (BUT STILL ATTACHED TO CATHETER). THE PHYSICIAN WAS ABLE TO PUSH THE CATHETER BACK IN AND REMOVE THE BALLOON OVER THE CATHETER WITHOUT ANY RESIDUAL EFFECTS TO THE PATIENT. THERE WERE NO DETACHED COMPONENTS. THERE WAS NO DEFLATION DIFFICULTIES NOTED. THE BALLOON WAS FULLY DEFLATED PRIOR TO REMOVAL ATTEMPT. NO VESSEL DAMAGE WAS NOTED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10703249 ↗
• InjuryMay 21, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A NANOCROSS 014 PTA BALLOON TO TREAT A MODERATELY CALCIFIED, SLIGHTLY TORTUOUS PLAQUE CHRONIC TOTAL OCCLUSION(CTO, 100% STENOSIS) LESION IN THE RIGHT DISTAL POPLITEAL & SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 6MM & 350MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST/SALINE SOLUTION WAS USED AS INFLATION FLUID. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. IT WAS REPORTED THAT ON THE 4TH OR 5TH INFLATION TO 10ATM, THE BALLOON RUPTURED FOLDING OVER ON ITSELF. A SNARE WAS USED TO RETRIEVE THE BALLOON AND THE PROCEDURE WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8627166 ↗

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,