NanoCross™ Elite AB14W025210150 (UDI 00763000109721)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000109721), received between Dec 17, 2019 and Aug 7, 2025 — classified as 1 death, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DEVICE FOR PATIENT TREATMENT IN THE ANTERIOR TIBIAL ARTERY. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THERE WAS A BALLOON TWIST NOTED DURING THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737904 ↗
• MalfunctionAug 23, 2024Burst Container or Vessel; Burst Container or Vessel

  A NANOCROSS PTA BALLOON WAS INTENDED TO BE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED BALLOON BURST AT AN UNKNOWN PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056398 ↗
• MalfunctionJul 12, 2024Burst Container or Vessel; Burst Container or Vessel

  A NANOCRSOSS PTA BALLOON WAS BEING USED FOR TREATMENT OF A 250MM CALCIFIED LESION WITH 80-95% STENOSIS IN THE PROXIMAL REGION OF THE LEFT  ANTERIOR TIBIAL ARTERY. THE ARTERY WAS 2.5MM IN DIAMETER WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY. THERE WERE NO ABN ORMALITIES REPORTED IN RELATION TO ANATOMY. A 6FR NON MEDTRONIC SHEATH WAS USED. A SPIDER FX WAS USED FOR EMBOLIC PROTECTION. THE VESSEL WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE WHEN ADVANCING THE NANOCROSS PTA BALLOON. THE DEVICE DID NO PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. THE IFU WAS FOLLOWED. IT WAS REPORTED DURING THE FIRST INFLATION THE BALLOON BURST AT 8ATM. THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. THE BALLOON DID NOT DETACH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER NANOCROSS PTA BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729003 ↗
• MalfunctionApr 15, 2024Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USING A NANOCOSS PTA BALLOON FOR TREATMENT OF AN UNKNOWN LESION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO THE LESION. IT WAS REPORTED THE BALLOON BURST BEFORE REACHING RBP. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105599 ↗
• MalfunctionFeb 7, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NANOCROSS TO TREAT A FIBROUS LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS 80%. EMBOLIC PROTECTION WAS NOT USED. A BOSTON INFLATION DEVICE WAS USED. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. BALLOON DEFLATION DIFFICULTIES OCCURRED. DEVICE WOULD NOT DEFLATE AT THE LESION SITE. BALLOON REMOVED INFLATED THROUGH SHEATH AND NEW BALLOON USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658582 ↗
• MalfunctionDec 4, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NANOCROSS DILATATION BALLOON TO TREAT A LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY. A SPIDER 3MM WAS USED FOR EMBOLIC PROTECTION. A INDEFLATOR INFLATION DEVICE WAS USED. DEVICE WAS PREPPED WITH NO ISSUES AND PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS A LONGITUDINAL BALLOON BURST DURING BALLOON INFLATION. ALL FRAGMENTS WERE RETRIEVED. PROCEDURE WAS COMPLETED AS NORMAL. NO INJURY TO THE PATIENT WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255155 ↗
• DeathOct 16, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S DISTAL PERONEAL ARTERY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MEDTRONIC (BOSTON SCIENTIFIC) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION IS REPORTED. THE BALLOON CAME OFF THE DELIVERY CATHETER AND HAD TO BE SURGICALLY REMOVED FROM THE PERONEAL ARTERY. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY, STEEP AORTO/ILIAC BIFURCATION WAS REPORTED. PATIENT WAS ALIVE AND WELL AFTER THE BALLOON WAS SURGICALLY REMOVED. PATIENT EXPIRED 2 DAYS LATER DUE TO MYOCARDIAL INFARCTION. THE PHYSICIAN REPORTED THAT THE DETACHMENT AND SURGICAL REMOVAL OF THE NANOCROSSELITE BALLOON FROM THE PERONEAL ARTERY CONTRIBUTED TO THE MI AND DEATH.

  Patient problems: Myocardial Infarction

  MAUDE report 17938308 ↗
• MalfunctionMar 31, 2023Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON FOR THE TREATMENT OF A 200MM LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL REGION OF THE POPLITEAL ARTERY. A 4FR SHEATH AND A 0.014 GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING A INSUFFLATOR AT THE ATM THAT IS INDICATED ON THE BOX BY IFU. IT WAS REPORTED THE BALLOON DID NOT INFLATE, THE BALLOON WAS DEFLATED AND REMOVED WITHOUT ANY DAMAGE TO THE PATIENT. WHEN IT WAS REMOVED IT WAS NOTED THE BLUE PLASTIC OF THE BALLOON WAS DETACHED, DETACHMENT OCCURRED IN THE VESSEL AND THE DETACHED COMPONENT WAS REMOVED. NO DETACHED PARTS REMAIN IN THE PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656043 ↗
• MalfunctionSep 22, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT PROXIMAL PERONEAL ARTERY WITH 40% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. EVEREST INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 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, BALLOON BURST OCCURRED 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. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469217 ↗
• MalfunctionApr 4, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON ALONG WITH 6FR SHEATH AND NON-MEDTRONIC 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID POSTERIOR TIBIAL ARTERY (PTA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2.5MM AND 280MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A 50/50 CONTRAST WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT LONGITUDINAL BALLOON BURST OCCURRED AT 8ATM DURING BALLOON INFLATION. EVENT OCCURRED ON THE FIRST INFLATION. 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. IT WAS REPORTED THAT THE NANOCROSS TAPERED BALLOON WAS INFLATED IN THE PATIENT TO 8 ATMS AND RUPTURED ON THAT I NFLATION. BALLOON AND CATHETER WAS REMOVED FROM PATIENT WITH NO ISSUES. ANOTHER NANOCROSS TAPERED BALLOON WAS OPENED AND USED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13993769 ↗
• MalfunctionSep 22, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 5FR SHEATH AND 0.014"GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE RIGHT MID PEDAL ARTERY WITH 80% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2.5MM AND 200MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. CONTRAST WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, IT BURST AT 10ATM DURING THE SECOND INFLATION. NO INTERVENTION WAS NEEDED TO REMOVE FRAGMENTS FROM PATIENT. NO VESSEL INJURY OCCURRED. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON AND NO OTHER ISSUES OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511573 ↗
• MalfunctionJun 30, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS PTA BALLOON DURING PATIENT TREATMENT. 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. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED. IT IS REPORTED PRIOR TO REACHING RATED BURST PRESSURE (RBP), THE BALLOON BURST. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091644 ↗
• MalfunctionMar 26, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA ALONG WITH NON-MEDTRONIC 6FR 90CM SHEATH AND 0.014" 300CM GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT MID ANTERIOR TIBIAL ARTERY (ATA) CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH ARE 2MM AND 180MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED. A 50/50 CONTRAST WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING BALLOON INFLATION, BALLOON BURST AT 10ATM AT FIRST INFLATION. ALL BALLOON FRAGMENTS WERE RETRIEVED. THE INTERVENTION WAS REQUIRED TO REMOVE BALLOON FRAGMENTS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. AFTER THE BALLOON RUPTURED, THE PHYSICIAN DECIDED TO END THE PROCEDURE. NO VESSEL DAMAGE NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575550 ↗
• MalfunctionJan 19, 2021Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  PHYSICIAN INTENDED TO USE A NANOCROSS PTA BALLOON DURING PATIENT TREATMENT. IT IS REPORTED THE WIRE PART OF THE NANOCROSS WAS CROOKED AND WHEN THE PHYSICIAN INFLATED THE BALLOON, A BURST OCCURRED. THE PHYSICIAN REMOVED THE NANOCROSS BALLOON FROM THE PATIENT AND USED AN INPACT ADMIRAL TO TREAT THE STENOSIS IN THE ARTERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193774 ↗
• MalfunctionAug 11, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A NANOCROSS PTA BALLOON DURING TREATMENT OF THE PATIENT¿S ANTERIOR TIBIAL ARTERY. IFU WAS FOLLOWED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED A BURST OR LEAK OR BURST OCCURRED ON THE CATHETER DURING BALLOON INFLATION. ALL FRAGMENTS RETRIEVED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE WAS NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389501 ↗
• MalfunctionDec 17, 2019Fracture; Difficult to Remove; Physical Resistance/Sticking; Fracture; Difficult to Remove; Physical Resistance/Sticking

  PHYSICIAN USED NANOCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE DISTAL POSTERIOR TIBIAL ARTERY (PTA) WITH 30% STENOSIS. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING REMOVAL OF BALLOON POST PTA, DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION OCCURRED AND THE DEVICE FRACTURED. NO PORTION OF THE DEVICE REMAIN IN PATIENT. IT WAS REPORTED THAT THE BALLOON WAS PULLED APART DURING REMOVAL AND BOTH PIECES REMAINED ON THE BALLOON CATHETER SHAFT UPON RETRIEVAL. THE BALLOON AND WIRE WERE REMOVED TOGETHER, BOTH PIECES INTACT. PHYSICIAN HAD TROUBLE ADVANCING ANOTHER WIRE THROUGH THE EXISTING SHEATH, THE EXISTING SHEATH WAS REMOVED AND A NEW SHEATH WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480213 ↗

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,