Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL4060Recalls & reported problems
Shockwave Medical, Inc. · The Shockwave M5+ 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 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000218), received between Oct 21, 2025 and Sep 2, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Difficult to Remove1
- Failure to Deflate1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50576271 ↗MalfunctionOct 21, 2025Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate; Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate
A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE BALLOON WAS INFLATED AT 4 ATM AND A TOTAL OF 90 IVL PULSES WERE DELIVERED. HOWEVER, THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON BETWEEN IVL CYCLES. THE BALLOON WAS PULLED INTO THE SHEATH AND SUBSEQUENTLY BURST. THE BALLOON SHAFT WAS REMOVED, LEAVING THE PLASTIC WITHIN THE TIP OF THE SHEATH. THE PHYSICIAN THEN WENT NEGATIVE ON THE SHEATH SIDE PORT AND PULLED THE BROKEN BALLOON OUT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353542 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.