NanoCross™ Elite AB14W030210150 (UDI 00763000109882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000109882), received between Nov 25, 2020 and Jan 20, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING THE PERONEAL ARTERY, A NANOCROSS 014 BALLOON WAS USED, AND A BALLOON TWIST OCCURRED. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. THE DEVICE WAS REMOVED WITH A SNARE. SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW MEDTRONIC DEVICE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191387 ↗
• MalfunctionMay 8, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NANOCROSS TO TREAT A LESION. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED. THE  DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. BURST/LEAK AT THE CATHETER DURING INFLATION AT 10ATM IS REPORTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885572 ↗
• InjurySep 15, 2022Burst 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 ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER WITH A 5FR NON-MEDTRONIC SHEATH AND A 0.14 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 250MM CALCIFIED LESION IN PATIENTS PROXIMAL MID DISTAL POSTERIOR TIBIAL ARTERY. NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 2.5/3MM. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. SALINE AND CONTRAST INFLATION FLUID WAS USED. 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT DURING BALLOON INFLATION A LONGITUDINAL BALLOON BURST AT 12ATM OCCURRED. 1 PRIOR INFLATION WERE APPLIED TO THE DEVICE. THE BALLOON FRAGMENTED AND ALL PARTS OF THE BALLOON WERE REMOVED. DURING THE REMOVAL OF BALLOON, BALLOON CATHETER DETACHED FROM PROXIMAL PART OF THE BALLOON. PHYSICIANS SNARED PROXIMAL END OF THE S

  Patient problems: Foreign Body In Patient

  MAUDE report 15427103 ↗
• InjuryAug 11, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER WITH A 6FR SHEATH AND A 014 GUIDEWIRE DURING TREATMENT OF A 3-5 MM CALCIFIED LESION IN PATIENTS MID POSTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 2.5MM. CONTRAST/SALINE INFLATION FLUID WAS USED. 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, DEVICE WOULD NOT DEFLATE AT THE LESION SITE. DEVICE MOVED IN LESION WHILE INFLATED. REMOVAL OF BALLOON WITH MARKERS IN PATIENT AND REMOVED WITH SNARES TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209212 ↗
• MalfunctionAug 19, 2021Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING THE TREATMENT OF A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT DISTAL POSTERIOR TIBIAL ARTERY. ARTERY DIAMETER 3.0MM DOWN TO 2.5MM AND APPROXIMATELY 250MM IN LENGTH. A 6FR NON MEDTRONIC SHEATH AND .014 NON MEDTRONIC GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION WAS USED. BALLOON WAS INFLATED WITH 50/50 SALINE CONTRAST USING A NON MEDTRONIC INFLATION DEVICE. DEVICE PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT LONGITUDINAL BALLOON BURST OCCURRED DURING INFLATION AT 8ATM'S. ONE INFLATION APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. ALL FRAGMENTS OF THE BALLOON RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING DEVICE. NO EXCESSIVE FORCE USED. THIS PARTICULAR BALLOON WAS USED AS A PRE-DILATATION BALLOON. THE DOCTOR SLOWLY TOOK THE BALLOON UP TO 8 ATM. AFTER THE BALLOON RUPTURED, IT ACCORDION AND BROKE INTO THREE PIECES. WITH MUCH DIFFICULTY AND ANXIETY, THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON AND ALL OF THE PIECES. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NON MEDTRONIC BALLOON. THE PATIENT WAS NOT INJURED AND THE PROCEDURE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340897 ↗
• InjuryAug 5, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT THE TIBIAL ARTERY. AN 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. IT WAS REPORTED THAT DURING BALLOON INFLATION, A BURST OCCURRED WITH UNKNOWN BURST TYPE. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED. THE PTA WAS SNARED AND REMOVED. NO FURTHER INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Tissue Injury

  MAUDE report 12281274 ↗
• MalfunctionMar 19, 2021Difficult to Remove; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 6FR 65CM SHEATH AND 0.014" GUIDEWIRE AND DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN DISTAL POSTERIOR TIBIAL ARTERY (PTA) WITH 80% STENOSIS. THE VESSEL WAS LITTLE TORTUOSITY. NON-MEDTRONIC INFLATION DEVICE 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. IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON WOULD NOT COME OFF OF WIRE, SO WIRE AND BALLOON WAS REMOVED TOGETHER SIMULTANEOUSLY. THE BALLOON WAS FULLY DEFLATED PRIOR TO WITHDRAWAL. THERE WAS NO VESSEL DAMAGE NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11525292 ↗
• MalfunctionJan 13, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A NANOCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL AND MID ANTERIOR TIBIAL ARTERY. MODERATE VESSEL CALCIFICATION AND NO TORTUOSITY ARE 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. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. 50% CONTRAST 50% SALINE WAS USED FOR BALLOON INFLATION. IT IS REPORTED A LONGITUDINAL BURST OCCURRED ON THE BALLOON AT AN INFLATION PRESSURE OF 14ATM. THE BURST OCCURRED ON FIRST INFLATION. ALL FRAGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167107 ↗
• MalfunctionNov 27, 2020Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE BALLOON CATHETER TO TREAT A CALCIFIED LESION IN A PATIENT. A NON MEDTRONIC INFLATION DEVICE WAS USED AND THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A LONGITUDINAL BURST OCCURRED DURING BALLOON INFLATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10913270 ↗
• InjuryNov 25, 2020Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE AND NANOCROSS PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID AND DISTAL POSTERIOR TIBIAL ARTERY, ANTERIOR TIBIAL ARTERY, AND PERONEAL ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE WERE USED. IFU WAS FOLLOWED AND THE HAWKONE DEVICE WAS PREPPED WITHOUT ISSUE. THE GUIDEWIRE WAS HYDRATED AT PREP. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED THAT THE DEVICE LOCKED UP ON THE WIRE AND COULD NOT BE REMOVED OVER IT. THE HAWKONE AND WIRE WERE REMOVED IN TANDEM. FOLLOWING THIS A NANOCROSS PTA BALLOON WAS USED FOR TREATMENT. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING WITHOUT ISSUE. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. FOLLOWING INFLATION AT THE TARGET SITE, THE BALLOON WOULD NOT DEFLATE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10904323 ↗

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,