CROSSLOOP LPM01830PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327155403), received between Jul 17, 2026 and Jul 21, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Material Separation

  IT WAS REPORTED THAT AN ASAHI CROSSLOOP GUIDE WIRE WAS USED FOR A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY (ATA). THE CROSSLOOP GUIDE WIRE WAS TORQUED THREE TIMES CLOCKWISE AND THEN THREE TIMES COUNTERCLOCKWISE TO CROSS THE LESION. THE CROSSLOOP GUIDE WIRE WENT OUT OF THE VESSEL DURING MANIPULATION AND THE TIP OF GUIDE WIRE WAS FRACTURED. AS A REMEDIAL ACTION, A SURGICAL INCISION WAS PERFORMED TO REMOVE THE GUIDE WIRE FRAGMENT, AND THE GUIDE WIRE FRAGMENT WAS SUCCESSFULLY REMOVED. DUE TO THE HEAVY CALCIFICATION OF THE VESSEL, IT WAS DETERMINED THAT NO ADDITIONAL TREATMENT FOR THE PERFORATION WAS NECESSARY. IN ADDITION, THE ATTEMPT TO CROSS THE LESION WAS ABANDONED AND THE PROCEDURE WAS DISCONTINUED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED.MFR REPORT #: 3003775027-2026-00141

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892001 ↗
• InjuryJul 17, 2026Material Separation

  IT WAS REPORTED THAT AN ASAHI CROSSLOOP GUIDE WIRE WAS USED FOR A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY (ATA). THE CROSSLOOP GUIDE WIRE WAS TORQUED THREE TIMES CLOCKWISE AND THEN THREE TIMES COUNTERCLOCKWISE TO CROSS THE LESION. THE CROSSLOOP GUIDE WIRE WENT OUT OF THE VESSEL DURING MANIPULATION AND THE TIP OF GUIDE WIRE WAS FRACTURED. AS A REMEDIAL ACTION, A SURGICAL INCISION WAS PERFORMED TO REMOVE THE GUIDE WIRE FRAGMENT, AND THE GUIDE WIRE FRAGMENT WAS SUCCESSFULLY REMOVED. DUE TO THE HEAVY CALCIFICATION OF THE VESSEL, IT WAS DETERMINED THAT NO ADDITIONAL TREATMENT FOR THE PERFORATION WAS NECESSARY. IN ADDITION, THE ATTEMPT TO CROSS THE LESION WAS ABANDONED AND THE PROCEDURE WAS DISCONTINUED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851292 ↗