Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL2512Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00195451000591), received between Apr 3, 2026 and Sep 23, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component1
- Inflation Problem1
- Material Split, Cut or Torn1
Patient problems
- Perforation of Vessels2
- Cardiac Enzyme Elevation1
- Chest Pain1
- Foreign Body In Patient1
- Low Blood Pressure/ Hypotension1
- Myocardial Infarction1
- No Clinical Signs, Symptoms or Conditions1
- Non specific EKG/ECG Changes1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50876183 ↗InjurySep 9, 2026Material Split, Cut or Torn
Patient problems: Perforation of Vessels
MAUDE report 50701999 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
A Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) catheter was used to treat an unspecified lesion. It was reported that during IVL treatment, a vessel rupture/perforation was reported following the delivery of approximately 30 pulses at 4 atmospheres (atm). It was reported that the procedure was interrupted and the planned treatment could not be fully completed. The patient was admitted for observation and was reported to be doing well. No additional patient outcome information was provided. Multiple attempts have been made to obtain additional information regarding the event, including procedural details, patient outcome, and any interventions performed; however, no further information has been provided to date. There was no IVL malfunction reported.
Patient problems: Perforation of Vessels
MAUDE report 50487899 ↗MalfunctionApr 3, 2026Inflation Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHILE USING THE SHOCKWAVE C2 AERO CATHETER, THE BALLOON DID NOT FILL PROPERLY WITH THE CONTRAST/SALINE SOLUTION, REQUIRING INFLATION, DEFLATION, AND RE-INFLATION OF THE BALLOON.
Patient problems: Cardiac Enzyme Elevation; Chest Pain; Low Blood Pressure/ Hypotension; Myocardial Infarction; Non specific EKG/ECG Changes
MAUDE report 24781042 ↗
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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