NanoCross™ Elite AB14W050150150 (UDI 00763000110345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000110345), received between Aug 26, 2020 and Jun 11, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 11, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 45CM 6FR NON-MEDTRONIC SHEATH AND A 300CM .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED WITH THE 5X150 NANOCROSS BALLOON. A MEDTRONIC AC3200 INFLATION DEVICE WAS USED. 60/40 SALINE TO CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. BALLOON INFLATION AND DEFLATION DIFFICULTIES WERE REPORTED. THE BALLOON WAS NOT FULLY DEFLATED FOR REMOVAL. PHYSICIAN CUT THE HUB OF THE CATHETER TO PARTIALLY DEFLATE BALLOON. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH NO MORE ANGIOPLASTY N ECESSARY. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508633 ↗
• MalfunctionMar 5, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NANOCROSS ELITE TO TREAT A CALCIFIED PLAQUE LESION IN THE LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS 100%. A 7X45 TERUMO DESTINATION SHEATH WAS USED. A 6.0 SPIDER FILTER WIRE WAS USED AS GUIDEWIRE AND EMBOLIC PROTECTION. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. 50/50 CONTRAST INFLATION FLUID WAS USED. IFU WAS FOLLOWED WITHOUT ISSUE. DEFLATION DIFFICULTIES OCCURRED. NO ISSUES NOTED DURING INFLATION. NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WAS NOT FULLY DEFLATED FOR REMOVAL. THE PHYSICIAN GENTLY PULLED THE INFLATED BALLOON IN TANDEM THROUGH THE SHEATH WITH NO TRAUMA TO THE VESSEL WALL, VERIFIED THROUGH ANGIOGRAPHY. THE BALLOON CATHETER DID NOT CATCH UPON THE SHEATH DURING WITHDRAWAL. DEVICE WAS SAFELY REMOVED. NO INJURY/INTERVENTION. PROCEDURE COMPLETED BY USING A AB14W050120150 WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837678 ↗
• MalfunctionAug 4, 2023Leak/Splash; Leak/Splash

  A NANOCROSS ELITE BALLOON AND AN EVERCROSS BALLOON WERE USED DURING TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID RIGHT REGION OF THE EVENT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 4-7MM IN DIAMETER WITH SEVERE CALCIFICATION AND NO TORTUOSITY. THE NANOCROSS WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A 6FR NON MEDTRONIC SHEATH AND A SPIDER GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED USING A NON MEDTRONIC INFLATION DEVICE. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY.  IT WAS REPORTED DURING INFLATION A PIN HOLE LEAK OCCURRED AT 10 ATM. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. A NEW PTA WAS OPENED TO PROCEED. A 6FR NON MEDTRONIC SHEATH AND SPIDER GUIDEWIRE WERE USED WITH THE EVERCROSS DEVICE. A 4MM EMBOLIC PROTECTION DEVICE WAS ALSO USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE EVERCROSS CATHETER KINKED ON THE SHAFT DURING ADVANCEMENT. BOTH DEVICES RETRIEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457947 ↗
• MalfunctionSep 16, 2021Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS ELITE PTA BALLOON DURING PROCEDURE TO TREAT MODERATELY CALCIFIED FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL HAD MODERATE TORTUOSITY. A MEDTRONIC INFLATION DEVICE WAS USED. 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. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THERE WERE DEFLATION DIFFICULTIES, AND THE BALLOON WAS SLOW TO DEFLATE AT THE LESION SITE. THE PHYSICIAN HAD TO ATTEMPT DEFLATION OF THE BALLOON FOR SEVERAL MINUTES UNTIL HE COULD SAFELY REMOVE THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480679 ↗
• MalfunctionJan 6, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON AND NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A 200MM LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). HEAVY CALCIFICATION AND MINIMAL TORTUOSITY ARE REPORTED. LESION EXHIBITED 90% STENOSIS. THE VESSEL DIAMETER IS REPORTED AS 6MM. THERE WAS NO DAMAGE NOTED TO THE PRODUCT(S) PACKAGING PRIOR TO USE NOR ANY ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. A 5FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE WERE USED DURING THE PROCEDURE. THE BALLOONS WERE INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND 50/50 FLUID SOLUTION. THE DEVICES WERE NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICES. IT IS REPORTED THAT A PINHOLE BURST OCCURRED ON BOTH THE EVERCROSS PTA BALLOON AND THE NANOCROSS ELITE PTA BALLOON. THE EVERCROSS PTA BALLOON IS REPORTED TO HAVE BURST AT 8ATM AND THE NANOCROSS ELITE PTA BALLOON IS REPORTED TO HAVE BURST AT 10ATM. THE PROCEDURE WAS THEN COMPLETED WITH A NON-MEDTRONIC STENT AND BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123007 ↗
• InjuryDec 9, 2020Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 5MM. A 0.014 GUIDEWIRE WAS USED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT FOR POST DILATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION AT A PRESSURE OF 14ATM. IT IS REPORTED THE BALLOON COULD NOT DEFLATE. THE BALLOON COULD NOT DEFLATE, SO THE PHYSICIAN USED NEGATIVE PRESSURE. THE BALLOON TOOK 15 MINUTES TO DEFLATE, AS IT WAS A LONG AND TOUGH CTO AND THE DISTAL END GOT STUCK AND CAUGHT IN THE SHEATH. TWO ADDITIONAL NANOCROSS ELITE PTA BALLOONS WHICH WERE PREPPED AS PER IFU WERE ATTEMPTED TO BE USED BUT COULD NOT BE DEFLATED AT THE LESION SITE. ALL COMPONENTS OF ALL DEVICES WERE REMOVED FROM THE PATIENT WITH NO INTERVENTION REQUIRED. THE DEFLATION ISSUES ARE REPORTED TO HAVE CAUSED THROMBOSIS. NO FURTHER INJURY REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10974782 ↗
• InjuryAug 26, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON WITH A NON-MEDTRONIC 6FR SHEATH AND NON-MEDTRONIC 0.014 GUIDEWIRE DURING TREATMENT OF A GREATER THAN 200MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND COMMON ILIAC ARTERY. ARTERY DIAMETER REPORTED AS 6MM. SEVERE VESSEL CALCIFICATION AND MODERATE TORTUOSITY ARE REPORTED. LESION EXHIBITED AREAS OF 50-90% STENOSIS. NO DAMAGE WAS 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 INFLATION DEVICE WAS USED WITH 50/50 MIX HEP SALINE/CONTRAST INFLATION FLUID FOR BALLOON INFLATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED DURING INITIAL INFLATION A BALLOON BURST OCCURRED AT A PRESSURE OF GREATER THAN 14ATM. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL OF THE DEVICE. ALL BALLOON FRAGMENTS WERE RETRIEVED EXCEPT ONE MARKER WHICH OUT A BRANCH OFF THE COMMON FEMORAL ARTERY (CFA). SNARE DEVICES WERE USED TO RETRIEVAL. THE SHEATH WAS EXCHANGED FOR AN 8FR DURING THE RETRIEVAL PROCESS. FOLLOW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10453176 ↗

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,