Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL3512Recalls & reported problems
Shockwave Medical, Inc. · The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. · Class 3
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 00195451000614), received between Dec 15, 2025 and Mar 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Deflate2
Patient problems
- Insufficient Information1
- 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.
MalfunctionMar 11, 2026Failure to Deflate
A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT AN UNKNOWN LESION. IT IS UNKNOWN IF THE DEVICE WAS PREPPED SUCCESSFULLY, IF ANY PULSES WERE DELIVERED, OR IF THE SHOCKWAVE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE IVL BALLOON FAILED TO DEFLATE, AND IT WAS ADDRESSED BY APPLYING REPEATED NEGATIVE PRESSURE. THE IVL BALLOON DID NOT REQUIRE PUNCTURE. THE LENGTH OF TIME THAT THE IVL BALLOON COULD NOT BE DEFLATED IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT SEQUELAE.
Patient problems: Insufficient Information
MAUDE report 24573213 ↗MalfunctionDec 15, 2025Failure to Deflate; Failure to Deflate
A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. A TOTAL OF 10 IVL PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATMOSPHERE (ATM). IT WAS REPORTED THAT FOLLOWING PULSE DELIVERY, THE IVL BALLOON DEMONSTRATED DIFFICULTY INFLATING AND DID NOT FULLY DEFLATE AFTER USING THE INFLATION DEVICE AND A SYRINGE. THE BALLOON WAS MANUALLY DEFLATED TO A PARTIALLY INFLATED STATE AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE CATHETER WAS EXCHANGED FOR A SECOND IVL BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812482 ↗
Other Shockwave Intravascular Lithotripsy System devices
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL3012Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System9 deaths33 reports
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL2512Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System4 deaths26 reports
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3012Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System4 deaths24 reports
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL2512Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System6 deaths23 reports
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL3512Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System4 deaths21 reports
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL4012Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System2 deaths18 reports
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3512Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System7 deaths14 reports
- Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL3012Shockwave Medical, Inc. · Shockwave Intravascular Lithotripsy System2 deaths13 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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