Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL050080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000577), received between Apr 3, 2025 and Jun 19, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE PRE MARKET DISRUPT PAD JAPAN STUDY INVOLVING A SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. THE PATIENT WAS ENROLLED IN A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM INVESTIGATIONAL STUDY TO TREAT MODERATE AND SEVERELY CALCIFIED FEMOROPOPLITEAL ARTERIES. AN ANTICOAGULANT (HEPARIN) WAS ADMINISTERED DURING THE INDEX PROCEDURE AND POST-PROCEDURE. ANTIPLATELET THERAPY WITH ASPIRIN AND CLOPIDOGREL WAS RECORDED PRIOR TO THE INDEX PROCEDURE AND REMAINED ONGOING. IT WAS REPORTED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA, CURRENT SMOKER, CORONARY ARTERY DISEASE, PRIOR CORONARY STENTING OR BYPASS PROCEDURE, RENAL INSUFFICIENCY REQUIRING DIALYSIS (LAST DIALYSIS PERFORMED ON (B)(6) 2025), CEREBROVASCULAR ACCIDENT (MOST RECENT EVENT >60 DAYS PRIOR; 2026), ATRIAL FIBRILLATION, RESPIRATORY/PULMONARY DISEASE, LARYNGEAL CANCER, ENDOVASCULAR THERAPY PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY (EVT - LT SFA) WITH HOSPITALIZATION WITHIN THE PAST 60 DAYS (B)(6) 2025), AND PERIPHERAL PROCEDURES. ON (B)(6) 2025, THE SUBJECT UNDERWENT A SUCCESSFUL INDEX PROCEDURE FOR A TARGET LESION IN THE RIGHT SUPERFICIAL FEM

  Patient problems: Insufficient Information

  MAUDE report 25564158 ↗
• InjuryApr 3, 2025Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Split, Cut or Torn; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Split, Cut or Torn

  A SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS BEING USED TO TREAT THE LEFT ILIAC ARTERY. IT WAS REPORTED THAT DURING THE PROCEDURE A 6MM CATHETER, THE IVL CATHETER DEVICE BECAME STUCK ON A SPIDERWIRE EMBOLIC PROTECTION DEVICE. ATTEMPTS TO INFLATE THE IVL BALLOON FAILED, AND BLOOD WAS OBSERVED IN THE BALLOON ASPIRATION PORT. EFFORTS TO REMOVE THE CATHETER AND SPIDERWIRE WERE UNSUCCESSFUL, LEADING TO THE DEVICE BECOMING LODGED AT THE ENTRANCE OF THE DESTINATION SHEATH. UPON REMOVAL OF THE IVL CATHETER, A PORTION OF THE BALLOON WAS OBSERVED TO BE MISSING AND REMAINED IN THE PATIENT. MULTIPLE ATTEMPTS TO RETRIEVE THE MISSING BALLOON AND SPIDERWIRE WERE MADE, BUT THE SPIDER BASKET EVENTUALLY BROKE OFF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IVL PULSES HAD NOT BEEN DELIVERED, AND THE BALLOON HAD RUPTURED OR LOSS PRESSURE PRIOR TO ATTEMPTS TO REMOVE. THE PATIENT WAS CONVERTED TO SURGICAL CUT DOWN TO THE COMMON FEMORAL ARTERY (CFA) , SUCCESSFULLY REMOVING THE DEVICE, AND THE PATIENT WAS DISCHARGED AFTER FOLLOWING SURGERY WITH NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766997 ↗