Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter S4IVL2540 (UDI 00195451000041)Recalls & reported problems
Shockwave Medical, Inc. · The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195451000041), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Reduced Blood Flow1
- Restenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Material Split, Cut or Torn
THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET BTK II STUDY. ON (B)(6) 2022, A SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID POSTERIOR TIBIAL VESSEL. A TOTAL OF 154 IVL PULSES WERE DELIVERED AT 4 ATMOSPHERES OF PRESSURE (ATM) BEFORE THE BALLOON RUPTURED. HOWEVER, IT WAS REPORTED THAT THE SUBJECT HAD NO COMPLICATIONS FROM THE BALLOON RUPTURE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED WITH POST DILATION PERFORMED USING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE PATIENT WAS DISCHARGED THE SAME DAY AS THE INDEX PROCEDURE. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A CEREBROVASCULAR ACCIDENT (CVA), OR STROKE. IT WAS RESOLVED 2 DAYS AFTER, BUT THE TREATMENT PROVIDED IS UNKNOWN. THE CLINICAL SITE DETERMINED THAT THE CVA WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. IN A 6-MONTH FOLLOW-UP, AN ULTRASOUND SHOWED MONOPHASIC FLOW AND POSSIBLE RE-OCCLUSION. THE CLINICAL SITE DETERMINED NO FURTHER ACTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED, AND THE PATIENT OUTCOME IS UNKNOWN. THE CLINICAL SITE DETERMINED THAT THE POSTERIOR TIBIAL RE-OCCLUSION WAS P
Patient problems: Reduced Blood Flow; Restenosis
MAUDE report 24384339 ↗
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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