Auryon Atherectomy Catheter EXM-4012-H000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017590325), received between Nov 18, 2025 and Nov 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K241553); 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 18, 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.

• InjuryNov 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  LEFT PEDAL ACCESS, USED 2.0MM CATHETER IN DISTAL SFA TO DISTAL POP WITH DR. NJOH. BEFORE LASER, HE USED SHOCKWAVE AND DCB IN SFA/POP AND POBA IN TPT TO AT. AFTER THAT INITIAL TREATMENT, HE NOTICED SOME THROMBUS AND DECIDED ON 2.0 LASER CATHETER. SHEATH AND WIRE EXCHANGE OCCURRED BEFORE 2.0 INSERTION. 1 PASS AT 60 IN DISTAL SFA TO DISTAL POP- VERY SLOWLY DONE. PERFORATION IN POP RIGHT AT KNEE JOINT OCCURRED IMMEDIATELY AFTER LASER USE (PRE AND POST ANGIOGRAMS TAKEN TO PROVE).

  Patient problems: Perforation of Vessels

  MAUDE report 23582024 ↗
• InjuryNov 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A CLINICAL ASSOCIATE II REPORTED AN EVENT FOR AURYON ATHERECTOMY CATHETER 1.7MM - HYDROPHILIC COATED: RIGHT PERONEAL ARTERY ACCESS, DIFFICULTY GETTING ACCESS, MULTIPLE STICKS REQUIRED. ACCESS OBTAINED, SHEATH/CATHETER/WIRE INSERTED. FOR REASONS UNKNOWN, PHYSICIAN ONLY INSERTED TIP OF SHEATH IN ARTERY. ANGIOGRAPHIC AND IVUS IMAGES OBTAINED OF R LEG, FROM CFA TO MID PERONEAL. LESIONS IDENTIFIED IN SFA, POPLITEAL, AND TPT, WITH A MINOR LESION IN DISTAL PERONEAL ARTERY, JUST BEYOND TIP OF SHEATH. IVUS MEASURED PROXIMAL PERONEAL ARTERY AT >3.0MM. DECISION MADE TO TREAT SFA, POPLITEAL, AND TPT LESIONS WITH LASER AND PTA. AURYON 1.7 LASER INSERTED, HOWEVER, IT APPEARED LASER CATHETER WOULD NOT ADVANCE IN DISTAL PERONEAL, AND IT WAS PRESUMED TO BE AT SITE OF MINOR LESION. PHYSICIAN HAD THE LASER CATHETER ACTIVATED TO GET THROUGH THE LESION (50MJ FOR APPROX. 3-5 SECONDS). LASER CATHETER ADVANCED EASILY AFTER THAT, AND TARGET LESIONS WERE TREATED WITHOUT INCIDENT. AFTER ALL TREATMENT WAS COMPLETED, ANGIOGRAPHIC IMAGES OBTAINED OF TREATMENT AREAS, AND THEN CATHETER REMOVED FOR A "SHEATH SHOT" (WIRE AND SHEATH RETAINED, FINAL IMAGING OF MID/DISTAL ARTERY BEYOND SHEATH). IMAGES DEMONSTRATED CON

  Patient problems: Perforation of Vessels

  MAUDE report 23582019 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241553. One submission often covers many models, so check the product and lot details in each record.

• Z-0770-2025 · Nov 25, 2024 · Open, Classified
  AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100