Astato XS 20 PAGH143392Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04547327088305), received between Sep 26, 2019 and Jul 30, 2026 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

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.

• InjuryJul 30, 2026Material Separation

  It was reported that a percutaneous transluminal angioplasty (PTA) was performed for a chronic total occlusion (CTO) with moderately calcified fibrous cap of approximately 2cm in length in the mid anterior tibial artery (mid AT). An Asahi Astato XS 20 guide wire was advanced to the fibrous cap and torqued to penetrate the CTO, when the guide wire lodged in the cap. When the Astato XS 20 guide wire was removed, the wire tip was found left in the CTO. Additional attempts were made to cross the CTO with other guide wires but failed. The procedure was aborted at that point. It was informed that there was blood flow to the foot through the posterior tibial artery, while the AT remained occluded. Mfr Report #: 3003775027-2026-00147.

  Patient problems: Foreign Body In Patient

  MAUDE report 50086104 ↗
• InjuryJul 27, 2026Material Separation

  It was reported that a percutaneous transluminal angioplasty (PTA) was performed for a chronic total occlusion (CTO) with moderately calcified fibrous cap of approximately 2cm in length in the mid anterior tibial artery (mid AT). An Asahi Astato XS 20 guide wire was advanced to the fibrous cap and torqued to penetrate the CTO, when the guide wire lodged in the cap. When the Astato XS 20 guide wire was removed, the wire tip was found left in the CTO. Additional attempts were made to cross the CTO with other guide wires but failed. The procedure was aborted at that point. It was informed that there was blood flow to the foot through the posterior tibial artery, while the AT remained occluded.

  Patient problems: Foreign Body In Patient

  MAUDE report 50003511 ↗
• InjuryOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT STENTING WAS PERFORMED FOR A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL LEFT COMMON ILIAC ARTERY. A CHOICE PT GUIDE WIRE (BOSTON SCIENTIFIC) WAS INITIALLY USED BUT COULD NOT CROSS THE LESION. THE GUIDE WIRE WAS REPLACED BY AN ASAHI ASTATO XS 20 GUIDE WIRE, WHICH FAILED TO CROSS THE LESION AND WHOSE TIP WAS DETACHED IN THE SUBINTIMAL SPACE OF THE LESION. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE WIRE FRAGMENT AND TO LEAVE IT IN SITU. AN ASAHI ASTATO 30 GUIDE WIRE WAS THEN USED BUT ALSO FAILED TO CROSS THE LESION. THE GUIDE WIRE WAS THEN REPLACED BY A HI-TORQUE COMMAND ES GUIDE WIRE (ABBOTT VASCULAR), WHICH SUCCESSFULLY CROSSED THE LESION. BALLOON ANGIOPLASTY WAS PERFORMED, FOLLOWED BY STENT DEPLOYMENT TO COMPLETE THE PROCEDURE. IT WAS INFORMED THAT THE PATIENT HAS ALREADY RECOVERED AND BEEN DISCHARGED WITHOUT ANY COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23344898 ↗
• MalfunctionOct 20, 2025Material Fragmentation; Material Fragmentation

  FEMORAL ACCESS WAS GAINED WITH A 5FR SHEATH. IMAGES WERE TAKEN OF ILIACS. A BOSTON SCIENTIFIC PT EXTRA SUPPORT .014/300CM WIRE AND (BRAND UNKNOWN) SUPPORT CATHETER WERE INSERTED. CROSSING OF THE LESION FAILED, SO AN ASTATO XS 20 WAS EXCHANGED, ALSO UNABLE TO CROSS LESION, ASTATO XS 20 TIP BROKE OFF IN THE SUBINTIMAL SPACE OF CALCIFIED LESION. AN ASTATO 30 WAS ALSO EXCHANGED, UNABLE TO CROSS. AN ABBOTT HT COMMAND ES WAS EXCHANGED AND CROSSED LESION. A BOSTON SCIENTIFIC STERLING 5 X 20 BALLOON WAS USED, THE VOLCANO IVUS CATHETER WAS INSERTED FOR IMAGING, FOLLOWED BY A J & J SMART CONTROL 8 X 60 STENT WITH POST DILATATION USING A BOSTON SCIENTIFIC MUSTANG 7 X 60 BALLOON. PATIENT WAS RECOVERED AND DISCHARGED IN NORMAL PROTOCOL. NO COMPLICATIONS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341665 ↗
• DeathSep 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2020, THERE WAS A PLANNED PERCUTANEOUS CORONARY INTERVENTION OF BOTH THE LAD ARTERY AND RAMUS INTERMEDIUS ARTERIES WITH IMPELLA SUPPORT DUE TO SEVERELY DEPRESSED BIVENTRICULAR FUNCTION. THE RAMUS ARTERY WAS FIRST TREATED BY STENT DEPLOYMENT. AFTER STENTING OF THE RAMUS WAS COMPLETED, DECISION WAS MADE TO PERFORM CTO-PCI OF THE PROXIMAL-MID LAD THAT APPEARED HEAVILY CALCIFIED. MULTIPLE WIRES ATTEMPTED TO CROSS THE CTO INCLUDING ASAHI WIRES: PROWATER, FIELDER XT, GLADIUS MONGO 14, CONFIANZA PRO 12, USING A WIRE ESCALATION AND DE-ESCALATION STRATEGY AND THE USE OF A 150CM CORSAIR PRO XS MICROCATHETER. AFTER THE PROXIMAL CTO WAS CROSSED, THE DECISION WAS MADE TO ATTEMPT TO RE-ENTER THE TRUE LUMEN IN THE MID LAD WITH A STINGRAY BALLOON AND A STINGRAY GUIDE WIRE. A MIRACLEBROS 12 WAS PLACED INTO THE CORSAIR PRO XS TO EXCHANGE FOR A STINGRAY BALLOON. THE MIRACLEBROS 12 WAS IMMEDIATELY REMOVED AFTER THE STINGRAY BALLOON WAS IN PLACE, AND A STINGRAY WIRE WAS THEN ADVANCED THROUGH THE STINGRAY BALLOON FOR THE INITIAL ATTEMPT AT RE-ENTRY. UNSUCCESSFUL WITH THE STINGRAY GUIDEWIRE. THEN IT WAS ATTEMPTED WITH CONFIANZA PRO 12. UNSUCCESSFUL. ADVANCED THE STINGRAY BA

  Patient problems: Perforation of Vessels

  MAUDE report 10480720 ↗
• MalfunctionAug 27, 2020Break

  WHILE TRYING TO PENETRATE THIS HEAVILY CALCIFIED LAD WITH AN ASTATO XS 20 GUIDE WIRE WITH THE SUPPORT OF THE CORSAIR PRO XS MICROCATHETER(#7662), THE TIP OF THE CORSAIR PRO XS BROKE OFF OF THE DISTAL SEGMENT OF THE MICROCATHETER AND BECAME AFFIXED TO THE DISTAL SEGMENT OF THE ASTATO XS 20 GUIDE WIRE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 10463723 ↗
• InjuryOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UF REPORT #: (B)(4) WAS RECEIVED. IT WAS REPORTED AS FOLLOWS: ONCE WE HAD SET UP COMPLETED USING A .035" NAVI-CROSS AND A .014" COMMAND WIRE INITIAL ATTEMPT TO CROSS THE LESION IN THE PROXIMAL WAS UNSUCCESSFUL. THIS WAS THEN EXCHANGED FOR A WIRE, WHICH WAS ABLE TO BE ADVANCED, BUT IT WAS AT THIS POINT SUBINTIMAL. AT THIS POINT, USING A COMBINATIONS OF A COMMAND WIRE, WINN WIRE, A STATO WIRE, AND A GLIDE ADVANTAGE WIRE, WE TRIED TO GET BACK IN THE TRUE LUMIN WHICH WAS UNSUCCESSFUL. WE ATTEMPTED LOOPING THE WIRE WITH THE NECK, BUT THAT WAS ALSO SUCCESSFUL. AFTER SOME PERIOD OF TIME WE ELECTED TO SEE IF WE COULD TRY A REENTRY DEVICE. AS WE GOT DOWN TO THE DISTAL SFA, AT THIS POINT WHERE WE WERE ABLE TO CREATE A REENTRY SITE, I WAS ABLE TO GET MY WIRE TO GO BACK LUMINAL. THE NAVICROSS WAS ADVANCED AND 3CC INJECTION CONFIRMED INTRALUMINAL COURSE. THE WOUND WIRE WAS THEN EXCHANGED FOR A COMMAND WIRE AGAIN. THE NAVICROSS WAS REMOVED AND ATTEMPT TO ADVANCE WAS UNSUCCESSFUL DUE TO THE SIGNIFICANT OF THE LESIONS IN THE INTIMAL TRACT. WE THEN WENT IN WITH A 1.5 X 150 MM ARMADA BALLOON. IT WAS ABLE TO BE ADVANCED AND BALLOON INFLATION WAS PERFORMED FROM THE DISTAL TO THE OSTIUM. THE 2 X 200 MM

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9143612 ↗
• Oct 1, 2019Fracture; Malposition of Device

  DURING A LOWER EXTREMITY INTERVENTION THE GUIDE WIRE FRACTURED, LEAVING THE TIP OF THE WIRE IN THE BODY ENCLOSED IN THE STENT THAT WAS PLACED OVER THE LESION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141711 ↗
• MalfunctionSep 30, 2019Break; Use of Device Problem; Difficult to Advance

  PROCEDURE NOTE: ONCE WE HAD SET UP COMPLETED USING A .035" NAVI-CROSS AND A .014" COMMAND WIRE INITIAL ATTEMPT TO CROSS THE LESION IN THE PROXIMAL WAS UNSUCCESSFUL. THIS WAS THEN EXCHANGED FOR A WIRE, WHICH WAS ABLE TO BE ADVANCED, BUT IT WAS AT THIS POINT SUBINTIMAL. AT THIS POINT, USING A COMBINATIONS OF A COMMAND WIRE, WINN WIRE, ASTATO WIRE, AND A GLIDE ADVANTAGE WIRE, WE TRIED TO GET BACK IN THE TRUE LUMIN WHICH WAS UNSUCCESSFUL. WE ATTEMPTED LOOPING THE WIRE WITH THE NECK, BUT THAT WAS ALSO SUCCESSFUL. AFTER SOME PERIOD OF TIME WE ELECTED TO SEE IF WE COULD TRY A REENTRY DEVICE. AS WE GOT DOWN TO THE DISTAL SFA, AT THIS POINT WHERE WE WERE ABLE TO CREATE A REENTRY SITE, I WAS ABLE TO GET MY WIRE TO GO BACK LUMINAL. THE NAVICROSS WAS ADVANCED AND 3CC INJECTION CONFIRMED INTRALUMINAL COURSE. THE WOUND WIRE WAS THEN EXCHANGED FOR A COMMAND WIRE AGAIN. THE NAVICROSS WAS REMOVED AND ATTEMPT TO ADVANCE WAS UNSUCCESSFUL DUE TO THE SIGNIFICANT OF THE LESIONS IN THE INTIMAL TRACT. WE THEN WENT IN WITH A 1.5 X 150 MM ARMADA BALLOON. IT WAS ABLE TO BE ADVANCED AND BALLOON INFLATION WAS PERFORMED FROM THE DISTAL TO THE OSTIUM. THE 2 X 200 MM ARMADA BALLOON WAS ALSO EASILY ADVANCED INTO T

  Patient problems: Calcium Deposits/Calcification; Intimal Dissection

  MAUDE report 9137705 ↗
• InjurySep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UF REPORT #: (B)(4) WAS RECEIVED. IT WAS REPORTED THAT DURING A LOWER EXTREMITY INTERVENTION THE GUIDE WIRE FRACTURED, LEAVING THE TIP OF THE WIRE IN THE BODY ENCLOSED IN THE STENT THAT WAS PLACED OVER THE LESION.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9126811 ↗