Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL030080Recalls & reported problems
Shockwave Medical, Inc. · The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave E8 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195451000546), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 death.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE DISRUPT PAD JAPAN STUDY. ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) IDENTIFIED STENOTIC LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND ANTERIOR TIBIAL ARTERY (ATA) WITH SEVERE CALCIFICATION; A FILTRAP II 8.0 MM FILTER WAS PLACED IN THE POPLITEAL ARTERY BECAUSE RESIDUAL STENOSIS >50% WAS ANTICIPATED AFTER BALLOONING. SFA TREATMENT INCLUDED JETSTREAM ATHERECTOMY (2.4/3.4 MM), IVUS-GUIDED DETECTION OF PARTIAL THROMBUS WITH SUBSEQUENT ASPIRATION, FOLLOWED BY PLAIN OLD BALLOON ANGIOPLASTY (POBA) (APERTA NSE 7.0 × 40 MM) AND DRUG-COATED BALLOON ANGIOPLASTY (RANGER 7.0 × 60 MM); THE FILTRAP WAS THEN REMOVED. ATA TREATMENT INVOLVED WIRE EXCHANGE TO VASSALLO 14 (300 CM), POBA WITH A 2.0 × 40 MM BALLOON, AND INTRAVASCULAR LITHOTRIPSY (SHOCKWAVE 3.0 × 80 MM). A SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE FEMOROPOPLITEAL ARTERY. A TOTAL OF 400 IVL PULSES WERE SUCCESSFULLY DELIVERED. IVUS REVEALED INSUFFICIENT EXPANSION IN SOME AREAS; THEREFORE, ADDITIONAL POBA WAS PERFORMED USING A #14 SHIDEN HP 3.0 MM × 200 MM BALLOON. FINAL IVUS AND ANGIOGRAPHY CONFIRMED SATISFACTO
Patient problems: Insufficient Information
MAUDE report 23619720 ↗
Other Percutaneous Catheter, Ultrasound devices
- Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL7060Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound8 reports
- Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL080030Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound7 reports
- Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL120030Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound3 deaths7 reports
- Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL100030Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 deaths6 reports
- SEISMIQ™ FG-010978Bolt Medical, Inc. · Percutaneous Catheter, Ultrasound3 reports
- Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL5060Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
- Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL6560Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
- SEISMIQ™ FG-006917Bolt Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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