ASAHI SION AHW14R101SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547327132985), received between Sep 9, 2025 and Aug 10, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Separation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Material Separation

  It was reported that an Asahi SION guide wire was used during a percutaneous coronary intervention (PCI) to treat a modelately calcified lesion in the proximal left anterior descending artery (LAD). During the removal of the SION guide wire, the SION guide wire entered a subintimal space at the distal edge of the stent and was entrapped. The coil of the SION guide wire was unwound and fractured. An attempt was made to advance an unspecified microcatheter to the wire tip to facilitate retrieval; however, the attempt was unsuccessful. A TERUMO Runthrough guide wire was advanced into the vessel and an unspecified 2.0mm balloon catheter was inflated across the affected segment. The microcatheter was advanced over the SION guide wire. Inspection revealed that the fracture had occurred only at the extreme distal tip of SION guide wire, and the remainder of the SION guide wire was removed intact. Post-intervention angiography showed that the wire fragment was trapped by the newly deployed stent. It was informed that there was no adverse patient effect associated with this event and the patient was discharged in stable condition.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50189606 ↗
• InjuryAug 6, 2026Material Separation

  It was reported that an Asahi SION guide wire was used during a percutaneous coronary intervention (PCI) to treat a modelately calcified lesion in the proximal left anterior descending artery (LAD). During the removal of the SION guide wire, the SION guide wire entered a subintimal space at the distal edge of the stent and was entrapped. The coil of the SION guide wire was unwound and fractured. An attempt was made to advance an unspecified microcatheter to the wire tip to facilitate retrieval; however, the attempt was unsuccessful. A TERUMO Runthrough guide wire was advanced into the vessel and an unspecified 2.0mm balloon catheter was inflated across the affected segment. The microcatheter was advanced over the SION guide wire. Inspection revealed that the fracture had occurred only at the extreme distal tip of SION guide wire, and the remainder of the SION guide wire was removed intact. Post-intervention angiography showed that the wire fragment was trapped by the newly deployed stent. It was informed that there was no adverse patient effect associated with this event and the patient was dischagrged in stable condition.Mfr Report #: 3003775027-2026-00161

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50164779 ↗
• InjuryOct 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI SION GUIDE WIRE WAS USED FOR STENT DEPLOYMENT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT AN UNSPECIFIED LESION IN THE CORONARY ARTERY. WHEN REMOVED AFTER STENTING, THE SION GUIDE WIRE BECAME ENTANGLED IN THE STENT. THE GUIDE WIRE THEN BROKE OFF AND THE WIRE FRAGMENT WAS TRAPPED WITHIN THE STENT. IT WAS INFORMED THAT THE PROCEDURE WAS PROLONGED AND BECAME MORE COMPLEX DUE TO AN IATROGENIC DISSECTION BUT COMPLETED. THE CONDITION OF THE PATIENT WAS REPORTEDLY STABLE AFTER THE PROCEDURE AND THE PATIENT WAS RECOVERING WELL.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 23399635 ↗
• InjurySep 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MILDLY CALCIFIED AND MODERATELY TORTUOUS 90-99% STENOSIS IN THE LEFT CIRCUMFLEX ARTERY (LCX). DURING REMOVAL OF AN ASAHI SION GUIDE WIRE AFTER STENTING IN THE LCX, THE TIP OF THE SION GUIDE WIRE WAS UNRAVELLED AND EVENTUALLY SEPARATED. THE DISTAL SEGMENT OF THE SEPARATED WIRE TIP GOT STUCK IN THE STENT THAT WAS DEPLOYED IN THE LCX AND THE PROXIMAL SEGMENT OF THE FRAGMENT WAS EXTENDED INTO LEFT SUBCLAVIAN ARTERY. VOLCANO IVUS ON THE GUIDE WIRE THAT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) CONFIRMED THE WIRE FRAGMENT IN THE LEFT MAIN TRUNK (LMT). MULTIPLE GUIDE WIRES WERE USED TO RE-CROSS INTO THE STENT IN THE LCX, WITHOUT SUCCESS. THE PROCEDURE WAS THEN ABORTED. THE WIRE FRAGMENT WAS LEFT IN THE PATIENT ANATOMY. THE PATIENT HAD NO CHEST PAIN AND THE ELECTROCARDIOGRAM (ECG) WAS BASELINE THROUGHOUT THE PROCEDURE. IT WAS INFORMED THAT THE PATIENT WAS STABLE AFTER THE PROCEDURE. ANOTHER PCI WILL BE PERFORMED TO REMOVE THE WIRE FRAGMENT ONCE THE PATIENT'S KIDNEY FUNCTION HAS RETURNED TO NORMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23000994 ↗