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Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL6060 (UDI 00195451000171)Recalls & 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

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195451000171), received between Aug 18, 2022 and May 18, 2023 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Material Rupture2
  • Material Separation1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Foreign Body In Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

    IT WAS REPORTED THAT A SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR (IVL) LITHOTRIPSY CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE FEMORAL ARTERY. DURING THE TREATMENT, THE IVL BALLOON RUPTURED AFTER 6 CYCLES. WHEN THE PHYSICIAN PULLED THE CATHETER OUT OF THE INTRODUCER, IT WAS OBSERVED THAT THE TIP WAS MISSING. REPORTEDLY, THE TIP REMAINED IN THE FEMORAL ARTERY AND THE PHYSICIAN HAD TO INCISE THE ARTERY TO SURGICALLY REMOVE THE TIP. THE PHYSICIAN DID NOT USE ANOTHER IVL AS THE TREATMENT WAS DEEMED COMPLETE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE TO STAY IN THE HOSPITAL.

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

    MAUDE report 16955277 ↗
  • MalfunctionAug 18, 2022Material Rupture; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Rupture; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

    A M5 IVL PERIPHERAL CATHETER WAS USED TO TREAT THE SFA (SUPERFICIAL FEMORAL ARTERY). AFTER THE THIRD INFLATION, A BALLOON LOSS OF PRESSURE OCCURRED. A FRAGMENT OF THE BALLOON BECAME DETACHED AND PROCEEDED DOWNSTREAM. SURGERY WAS PERFORMED TO REMOVE THE DETACHED COMPONENT FROM THE PATIENT. THE PHYSICIAN BELIEVES THAT THE BALLOON LIKELY RUPTURED DUE TO CALCIUM. THE PATIENT IS WELL AND HAS SINCE BEEN DISCHARGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15254137 ↗

Other Percutaneous Catheter, Ultrasound devices

All Percutaneous Catheter, Ultrasound devices →

Sources and updates

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