MINAMO AH14R026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547327130745), received between Mar 11, 2020 and Sep 30, 2026 — classified as 4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Separation

  It was reported that an ASAHI MINAMO guide wire was used for a percutaneous coronary intervention (PCI) to treat an unspecified lesion in the coronary artery. The MINAMO guide wire was unraveled in the patient body. The physician tried to advance an IVUS catheter over the MINAMO guide wire, but the IVUS catheter got stuck. When the MINAMO guide wire was pulled out of the patient body, it was broken. It was informed that there was no adverse patient effect associated with this event and the patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942444 ↗
• InjurySep 29, 2026Material Separation

  It was reported that an ASAHI MINAMO guide wire was used for a percutaneous coronary intervention (PCI) to treat an unspecified lesion in the coronary artery. The MINAMO guide wire was unraveled in the patient body. The physician tried to advance an IVUS catheter over the MINAMO guide wire, but the IVUS catheter got stuck. When the MINAMO guide wire was pulled out of the patient body, it was broken. It was informed that there was no adverse patient effect associated with this event and the patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934447 ↗
• InjuryFeb 4, 2026Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A LESION IN THE RIGHT CORONARY ARTERY (RCA). AN ASAHI MINAMO GUIDE WIRE WAS ADVANCED INTO THE CORONARY ARTERY FOR STENTING. AFTER THE PROCEDURE WAS COMPLETED WITH STENT DEPLOYMENT, CORONARY COMPUTED TOMOGRAPHY REVELED A TIP FRAGMENT OF THE MINAMO GUIDE WIRE IN THE PATIENT ANATOMY. AS THE TIP FRAGMENT WAS FOUND AFTER COMPLETION OF THE PROCEDURE, NO ATTEMPTS WERE MADE TO RETRIEVE IT. THE PHYSICIAN COMMENTED THAT RESISTANCE WAS MET DURING REMOVAL OF THE MINAMO GUIDE WIRE AFTER DELIVERY OF THE STENT. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24264632 ↗
• MalfunctionFeb 4, 2026Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  THE WIRE WAS IN PLACE IN THE CORONARY ARTERY FOR PERCUTANEOUS CORONARY STENT PLACEMENT. AFTER STENT DEPLOYED, WIRE ATTEMPTED TO BE WITHDRAWN AND OPERATOR WAS MET WITH RESISTANCE WHICH WAS OVERCOME WHEN HYDROPHILIC TIP DISCONNECTED FROM WIRE AND WAS RETAINED IN STRUTS OF STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259111 ↗
• InjuryMay 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI MINAMO GUIDE WIRE WAS BROKEN AND RETAINED IN THE CORONARY ARTERY DURING PERCUTANEOUS CORONARY INTERVENTION TO TREAT A HEAVILY CALCIFIED AND TORTUOUS SUB-TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY. IT OCCURRED DURING INITIAL WIRING OF THE LESION, BEFORE PRE-DILATATION BALLOON INSERTION. NO MICROCATHETER WAS USED. THE PROCEDURE WAS TERMINATED AND UNSUCCESSFUL. NO ATTEMPTS WERE MADE TO RETRIEVE THE WIRE TIP. THE PATIENT REMAINED STABLE THROUGHOUT AND WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14441141 ↗
• MalfunctionMay 12, 2022Break

  DURING PCI, THE "TIP OF THE MINAMO WIRE" WAS BROKEN AND RETAINED IN THE CORONARY ARTERY. NO ADDITIONAL DETAILS WERE KNOWN. I WILL FOLLOW UP WITH ACCOUNT AND WILL BE ON-SITE ON MAY 17TH.

  Patient problems: Foreign Body In Patient

  MAUDE report 14367090 ↗
• MalfunctionMar 11, 2020Scratched Material

  DR. & STAFF NOTICED RIBBON DISTAL SEGMENT OF WIRE HAVING AN UNCOVERED PORTION 15MM BACK FROM DISTAL TIP OF WIRE, PRECEDED WITH THAT WIRE FOR CASE. PRE-DIL STENTED -POST DIL. COMPLETED CASE AND EVERYTHING REMOVED. NOTHING LEFT IN PATIENT. THEY WERE DISCHARGED -NO INJURY RECOVERED IN NORMAL FASHION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9821829 ↗