NanoCross™ Elite AB14W050150150 (UDI 00763000758165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000758165), received between Sep 3, 2024 and Apr 26, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 10, 2024Class IIOpen, Classified

   There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

   Z-0904-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 AND NANOCROSS ELITE BALLOON CATHETERS TO TREAT A SEVERELY CALCIFIED TARGET LESION IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE EVERCROSS 035 BALLOON BURST CIRCUMFERENTIALLY/RADIALLY ON THE FIRST INFLATION. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST, NO EMBOLIC PROTECTION WAS USED, THE VESSEL WAS PRE-DILATED, THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW BALLOON CATHETER WAS THEN USED. IT WAS FURTHER REPORTED THAT DURING CONTINUED TREATMENT WITH THE NANOCROSS ELITE BALLOON CATHETER, THE BALLOON BURST CIRCUMFERENTIALLY/RADIALLY ON THE FIRST INFLATION. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST, NO EMBOLIC PROTECTION WAS USED, THE VESSEL WAS POST-DILATED, THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED FOLLOWING THE NANOCROSS ELITE BALLOON BURST. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993871 ↗
• MalfunctionSep 10, 2025Deflation Problem; Deflation Problem

  A DEVICE WAS RETURNED TO CUSTOMER SERVICES AND ON INSPECTION OF THE DEVICE IT WAS NOTED THAT CRIMP MARKS WERE FOUND ON THE BALLOON BOND. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015332 ↗
• InjuryJan 7, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AN ATTEMPTED WAS MADE TO USE TWO (2) NANOCROSS ELITE BALLOONS IN A PATIENT TO TREAT THE PERIPHERAL ARTERY(S), S UPERFICIAL FEMORAL ARTERY. A NON-MEDTRONIC INFLATION DEVICE WAS USED (MERIT). 50/50 CONTRAST WAS USED. IT WAS REPORTED THAT DEFLATION DIFFICULTIES OCCURRED THAT TOOK 10 MINUTES TO DEFLATE. NEGATIVE PRESSURE WITH A SYRINGE WAS USED TO DEFLATE THE BALLOON AND THE BALLOON EVENTUALLY DEFLATED. DEFLATION DIFFICULTIES OCCURRED WITH 2 DEVICES. ANOTHER NANOCROSS ELITE BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO HEALTH CONSEQUENCES OR IMPACT TO A PATIENT WAS REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21090929 ↗
• InjuryJan 7, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AN ATTEMPTED WAS MADE TO USE TWO (2) NANOCROSS ELITE BALLOONS IN A PATIENT TO TREAT THE PERIPHERAL ARTERY(S), S UPERFICIAL FEMORAL ARTERY. A NON-MEDTRONIC INFLATION DEVICE WAS USED (MERIT). 50/50 CONTRAST WAS USED. IT WAS REPORTED THAT DEFLATION DIFFICULTIES OCCURRED THAT TOOK 10 MINUTES TO DEFLATE. NEGATIVE PRESSURE WITH A SYRINGE WAS USED TO DEFLATE THE BALLOON AND THE BALLOON EVENTUALLY DEFLATED. DEFLATION DIFFICULTIES OCCURRED WITH 2 DEVICES. ANOTHER NANOCROSS ELITE BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO HEALTH CONSEQUENCES OR IMPACT TO A PATIENT WAS REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21090602 ↗
• InjuryNov 1, 2024Deflation Problem; Deflation Problem

  A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON FOR TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER. A 6FR NON MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WAS USED. THE VESSEL WAS PRE-DILATED WITH ATHERECTOMY. IT IS NOT KNOWN IF THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. THE IFU WAS FOLLOWED. THERE WERE NO ISSUES ENCOUNTERED DURING BALLOON INFLATION AND NO DAMAGE NOTED TO THE BALLOON CATHETER. IT WAS REPORTED DEFLATION DIFFICULTIES OCCURRED, NEGATIVE PRESSURE WAS USED WITH A SYRINGE AND DEFLATION TOOK 3-4 MINUTES. THE DEVICE WAS SAFELY REMOVED FORM THE PATIENT. DELAYS IN SURGERY OF 10 MINUTES DUE TO PRODUCT MALFUNCTION. THE PROCEDURE WAS ABORTED. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585533 ↗
• MalfunctionOct 31, 2024Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NANOCROSS ELITE TO TREAT A LESION. DEFLATION DIFFICULTIES OCCURRED. BALLOON WOULD NOT DEFLATE. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS A 3 MINUTE DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576689 ↗
• InjuryOct 29, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  A NANOCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY (PERIPHERAL ARTERY(S)). THE IFU WAS FOLLOWED. AN UNKNOWN INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. IT WAS REPORTED THE BALLOON DID NOT INITIALLY INFLATE PROPERLY. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. THE BALLOON WAS NOT DEFLATING WITH THE INSUFFLATION DEVICE. AN EMPTY SYRINGE WAS ATTEMPTED TO BE USED TO PULL NEGATIVE PRESSURE, BUT IT WAS UNSUCCESSFUL. AN ATTEMPT WAS THEN MADE TO INTENTIONALLY PUNCTURE THE BALLOON WITH THE BACK END OF A NON MEDTRONIC WIRE. AFTER THAT FAILED, THE PHYSICIAN CUT THE HUB OF THE BALLOON TO TRY AND DRAIN THE FLUID AND ALLOW THE BALLOON TO DEFLATE. FINALLY AFTER 45 MINUTES OF TRYING TO DEFLATE THE BALLOON, THEY WERE ABLE TO PUNCTURE IT USING A NON MEDTRONIC CATHETER. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: Insufficient Information

  MAUDE report 20558141 ↗
• MalfunctionOct 9, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S RIGHT MID DISTAL SU PERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION WAS REPORTED. 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 HO OP/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. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. PHYSICIAN USED A SYRINGE AND NEGATIVE PRESSURE TO DEFLATE THE BALLOON. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL. THIS ISSUE IS REPORTED FOR 2 BALLOONS. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. PHYSICIAN SWITCHED TO A FORTREX HP PTA BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408329 ↗
• MalfunctionOct 9, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S RIGHT MID DISTAL SU PERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION WAS REPORTED. 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 HO OP/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. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. PHYSICIAN USED A SYRINGE AND NEGATIVE PRESSURE TO DEFLATE THE BALLOON. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL. THIS ISSUE IS REPORTED FOR 2 BALLOONS. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. PHYSICIAN SWITCHED TO A FORTREX HP PTA BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408183 ↗
• MalfunctionOct 8, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF THE PATIENT¿S LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). 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 OR POST DILATED. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. PHYSICIAN WAITED LONG ENOUGH UNTIL BALLOON DEFLATED ENOUGH TO REMOVE. DEFLATION TOOK OVER A MINUTE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395552 ↗
• MalfunctionSep 27, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 45 CM 6 FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150 MM CALCIFIED LESION IN THE PATIENT¿S RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 50% STENOSIS. ARTERY DIAMETER REPORTED AS 6 MM. 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 PRE-DILATED WITH A 3 X 150 NANOCROSS BALLOON. THE VESSEL WAS NOT POST-DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS PASSED THROUGH A PREVIOUSLY DEPLOYED 6 X 200 PROTÉGÉ STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WAS EVENTUALLY FULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320532 ↗
• InjurySep 3, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 7FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 2MM SOFT TISSUE LESION IN THE PATIENT¿S LEFT PROXIMAL CONTRALATERAL COMMON FEMORAL. MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION WERE REPORTED. LESION EXHIBITED NO STENOSIS. 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 PRE AND POST DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. NO ISSUES WERE NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WOULD NOT DEFLATE AND PULL BACK INTO CATHETER. THE BALLOON WAS NOT FULLY DEFLATED FOR REMOVAL. AFTER NOT DEFLATING WITH SYRINGE, PHYSICIAN P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125027 ↗