Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter C2AIVL3012Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00195451000607), received between Dec 3, 2025 and Sep 23, 2026 — classified as 2 deaths, 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (5 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Deflate

  A Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter was used to treat a lesion in the coronary artery.It was reported that after the catheter delivered 10 pulses, the physician attempted to deflate the balloon; however, the balloon would not deflate. Multiple attempts were made to deflate the balloon by attaching a syringe and aspirating, but these attempts were unsuccessful. The physician then intentionally overinflated the balloon several times to cause it to rupture, and the catheter was subsequently removed from the patient.A second Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter was opened and used; however, an Error 81 code was observed and could not be cleared. The procedure was subsequently completed successfully. The patient was reported to be recovering and was discharged per routine.This report is for the first catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871768 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  A Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter was used to treat a lesion in the right coronary artery (RCA).It was reported that a patient presented emergently with a ST-elevation myocardial infarction (STEMI) and was clinically unstable prior to Shockwave IVL treatment. Multiple inflations with non-IVL balloons were performed before the Shockwave IVL device was used. The IVL device was successfully prepared, and all 120 pulses were delivered. Post IVL treatment, a Grade 3 vessel perforation was identified in the distal RCA. The patient required urgent unplanned interventions, including pericardiocentesis and cardiopulmonary resuscitation (CPR). The procedure was completed by placement of two Papyrus covered stents and PTap was performed. Pre-dilation had been performed with a 2.0 mm Takeru balloon at 12 ATM and a 2.5 mm NC Euphora balloon at 20 ATM, followed by post-dilation with a 3.0 x 15 mm NC Euphora balloon. The procedure was completed using covered stents instead of the originally planned drug-eluting stents (DES) due to the perforation. The patient remained stable during the immediate procedure, but they subsequently died on 29Aug2026 after being placed

  Patient problems: Perforation

  MAUDE report 50725390 ↗
• MalfunctionAug 13, 2026Packaging Problem

  Patient problems: Insufficient Information

  MAUDE report 50244967 ↗
• DeathMay 29, 2026Material Split, Cut or Torn

  A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERY. IT WAS REPORTED THAT A PATIENT UNDERWENT A ROUTINE RADIAL HEART CATHETERIZATION WITH INTRAVASCULAR ULTRASOUND (IVUS) WHICH IDENTIFIED A CONCENTRIC LESION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A VESSEL DIAMETER OF 3.1 MM WITH CALCIFICATION. IN THE FIRST PROCEDURE, A 6F RADIAL SHEATH AND EXTRA BACKUP (EBU) 3.5 GUIDE WERE USED, WITH A 014 OMNI WIRE PLACED ACROSS THE MID-LAD AND SHOWED POSITIVE FRACTIONAL FLOW RESERVE (FFR). AFTER REMOVING THE 014 OMNI WIRE, A 014 RUNTHROUGH WIRE WAS ADVANCED ACROSS THE LESION. A 3.0X24 NON-COMPLIANT (NC) BALLOON WAS INFLATED TO NOMINAL PRESSURE. A PROPERLY PREPPED 3.0X12MM C2 AERO IVL CATHETER WAS PLACED AND CROSSED SUCCESSFULLY, BUT THE IVL BALLOON RUPTURED AFTER TWO CYCLES (20 PULSES) AT 4 ATMS. FOLLOWING THE IVL PROCEDURE, A TYPE 3 DISSECTION (MEASURING 20MM IN LENGTH) AND CORONARY PERFORATION WAS OBSERVED. A 3.0X38 DRUG-ELUTING SYNERGY STENT WAS DEPLOYED, FOLLOWED BY POST-DILATION WITH 3.0 AND 4.0 NC BALLOONS. REPEAT IVUS AT THAT TIME SHOWED A GOOD RESULT AND THE PATIENT WAS INITIALLY STABLE. SHORTLY AFTER RETURNI

  Patient problems: Cardiac Tamponade; Chest Pain; Hemorrhage/Blood Loss/Bleeding; Perforation; Vascular Dissection

  MAUDE report 25340763 ↗
• InjuryApr 24, 2026Material Split, Cut or Torn

  A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A CALCIFIED NODULAR LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS INITIATED VIA RIGHT RADIAL ARTERY ACCESS USING A 6 FR SHEATH. A JR4 6 FR GUIDING CATHETER WAS THEN ADVANCED TO ENGAGE THE RCA. A SHORT RUN-THROUGH GUIDEWIRE WAS PLACED INTO THE DISTAL POSTERIOR DESCENDING ARTERY (PDA). THE DISEASED SEGMENTS WERE PRE-DILATED USING A 2.5 × 15 MM BALLOON, PROGRESSING FROM THE PROXIMAL PDA THROUGH THE RCA. SUBSEQUENTLY, THE SHOCKWAVE C2 AERO IVL CATHETER WAS ADVANCED, AND MULTIPLE CYCLES OF LITHOTRIPSY WERE DELIVERED TO THE PROXIMAL TO MID PDA, DISTAL RCA, MID RCA, AND PROXIMAL RCA. 110 IVL PULSES WERE DELIVERED. DURING THE SECOND-TO-LAST INFLATION IN THE PROXIMAL RCA SEGMENT, ANGIOGRAPHY DEMONSTRATED BALLOON WASTE. THE BALLOON WAS INFLATED TO 6 ATM, AT WHICH POINT THE IVL BALLOON IMMEDIATELY RUPTURED, RESULTING IN ANGIOGRAPHIC DYE STAINING SUGGESTIVE OF A PERFORATION. AT THE FINAL LITHOTRIPSY RUN, ONE (1) BALLOON RUPTURE WAS CONFIRMED. THE IVL CATHETER SYSTEM WAS REMOVED. CONTINUOUS EXTRAVASCULAR DYE STAINING WAS OBSERVED; HOWEVER, ANGIOGRAPHIC INJECTION DEMONSTRATED NO ACTIVE EXTRAVAS

  Patient problems: Cardiac Tamponade; Chest Pain; Perforation of Vessels

  MAUDE report 24985560 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE PRE-MARKET FORWARD CAD IDE STUDY. THREE INVESTIGATIONAL SHOCKWAVE JAVELIN CORONARY (ARTEMIS) INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS AND TWO NON-INVESTIGATIONAL SHOCKWAVE C2 AERO CORONARY IVL CATHETERS WERE USED DURING AN IVL PROCEDURE ON (B)(6) 2026. THIS REPORT DOCUMENTS THE ADVERSE EVENT REPORTED IN ASSOCIATION WITH THE USE OF THE TWO SHOCKWAVE C2 AERO CORONARY IVL CATHETERS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN FOLLOWING THE PROCEDURE AND HAD A TRANSIENT HYPOTENSIVE EPISODE WITH BLOOD PRESSURE READINGS OF 84/61 MMHG AND 76/53 MMHG, WHICH RESOLVED SPONTANEOUSLY. THE INITIAL POST-PROCEDURE ECG (ELECTROCARDIOGRAM) DEMONSTRATED A NONSPECIFIC ST SEGMENT ABNORMALITY, WHILE SUBSEQUENT SECOND AND THIRD ECGS SHOWED INFERIOR ST SEGMENT ELEVATION. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LABORATORY (CATH LAB), WHERE A DIAGNOSTIC CORONARY ANGIOGRAM WAS PERFORMED. UPON THE PATIENT'S RETURN FROM THE CATH LAB, STUDY MANDATED CARDIAC BIOMARKERS WERE COLLECTED PER PROTOCOL, AS 12 HOURS HAD ELAPSED SINCE THE INDEX PROCEDURE. RESULTS SHOWED: CK MB (CREATINE KINASE-MYOCARDIAL BAND): 25.1 NG/ML (UPPER LIMIT OF NORMAL (ULN): 7.8 N

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Low Blood Pressure/ Hypotension; Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 24781077 ↗
• MalfunctionJan 28, 2026Crack; Inflation Problem; Failure to Deflate

  A SHOCKWAVE CORONARY C2 AERO INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. THERE WERE NO PROBLEMS REMOVING THE DEVICE FROM ITS PACKAGING OR REMOVING THE BALLOON PROTECTIVE SHEATH. THERE WAS SIGNIFICANT AIR PRESENT IN THE ENDOFLATOR TUBING. A NEW STOPCOCK AND ENDOFLATOR WERE THEN USED, AND A TOTAL OF 20 IVL PULSES WERE DELIVERED. HOWEVER, THE DISTAL BALLOON DID NOT FULLY INFLATE. A SMALL CRACK IN THE CATHETER HUB WAS REPORTED BY THE OPERATOR, AND THE BALLOON COULD NOT DEFLATE OR BE RETRIEVED. THUS, THE CATHETER SHAFT WAS CUT, AND THE BALLOON WAS ABLE TO DEFLATE AND BE SUCCESSFULLY RETRIEVED FROM THE PATIENT. A NEW 3.0MM SHOCKWAVE C2 AERO WAS USED WITHOUT ISSUES, DELIVERING ALL PULSES , AND THERE WERE NO PATIENT SEQUELAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205868 ↗
• InjuryJan 5, 2026Difficult to Remove

  A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION. A TOTAL OF 70 IVL PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATMOSPHERES (ATM). THE BALLOON WAS PREPARED WITH A 50/50 CONTRAST/SALINE MIXTURE AND PERFORMED TRIPLE NEGATIVE VACUUM USING A 3-WAY STOPCOCK AND A 20 CC SYRINGE. IT WAS REPORTED THAT DURING IVL TREATMENT, AFTER THE 7TH CYCLE THE BALLOON TOOK UNUSUALLY LONGER TO DEFLATE. THEREFORE, THE PHYSICIAN ELECTED TO SUSPEND CYCLE DELIVERY. THE IVL BALLOON WOULD NOT FULLY DEFLATE AFTER THE FIRST ONE TO TWO CYCLES SO THE INDEFLATOR WAS CHANGED AND A SYRINGE WAS USED TO ASPIRATE THE BALLOON WITH THE STOPCOCK TO FACILITATE DEFLATION. DURING ATTEMPTS TO DEFLATE THE BALLOON, THE PATIENT DEVELOPED TRANSIENT ST-SEGMENT ELEVATIONS. THE BALLOON WAS FULLY DEFLATED AND THE IVL CATHETER WAS REMOVED OVER THE WIRE AND OUT OF THE SHEATH WITHOUT FURTHER DIFFICULTY. THE ST ELEVATIONS WERE RESOLVED IMMEDIATELY FOLLOWING SUCCESSFUL DEFLATION OF THE BALLOON AND THE PATIENT RETURNED TO BASELINE. THE LESION WAS SUBSEQUENTLY STENTED AND POST DILATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS REPORTED

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23967990 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE CORONARY ARTERY. THE PHYSICIAN FIRST USED CSI FOLLOWED BY OPTICAL COHERENCE TOMOGRAPHY (OCT) WHICH SHOWED A DISSECTION JUST DISTAL TO A NODULAR LESION. THE PHYSICIAN THEN REQUESTED SHOCKWAVE C2 AERO CORONARY IVL CATHETER. AFTER 30 IVL PULSES WERE DELIVERED, A CORONARY PERFORATION OCCURRED. THE PHYSICIAN DEPLOYED TWO XIENCE STENTS AND PERFORMED 10 MINUTES OF BALLOON INFLATION. ECHOCARDIOGRAPHY WAS OBTAINED, PERICARDIOCENTESIS WAS PERFORMED, AND A PAPYRUS COVERED STENT WAS PLACED. THE PHYSICIAN BELIEVES THE CSI CAUSED THE INJURY. DIFFUSE CORONARY CALCIUM WAS NOTED AND THE VESSEL APPEARED TO SPLIT AFTER CSI AND BALLOONING. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE PATIENT REMAINED STABLE AND WAS DISCHARGED HOME.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 23924904 ↗
• MalfunctionDec 24, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE CORONARY ARTERY. THE DEVICE WAS PREPPED SUCCESSFULLY. AFTER 20 IVL PULSES WERE DELIVERED, THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON. THE PHYSICIAN CUT THE BACK OF THE BALLOON TO ALLOW CONTRAST TO DRAIN AND THE BALLOON TO PARTIALLY DEFLATE. THE BALLOON WAS THEN REMOVED BY ADVANCING A GUIDE-EXTENSION CATHETER OVER IT, WHICH DID NOT INVOLVE PUNCTURING THE BALLOON. THE BALLOON REMAINED UNABLE TO DEFLATE FOR ONLY A COUPLE OF MINUTES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT AND IS CURRENTLY DOING WELL. THE PATIENT DID NOT REQUIRE ADDITIONAL HOSPITALIZATION, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT HARM THAT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888683 ↗
• InjuryDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. IT WAS REPORTED THAT THE BALLOON RUPTURED AFTER FOUR (4) PULSES WHICH WAS OBSERVED UNDER FLUOROSCOPY AND CONTRAST STAINING. THE BALLOON WAS DEFLATED FOLLOWED BY ANGIOGRAPHY WHICH CONFIRMED A VESSEL PERFORATION. IT WAS NOTED THAT BALLOON TAMPONADE WAS APPLIED FOR SEVERAL MINUTES BUT BLEEDING PERSISTED, SO A DRUG ELUTING STENT (DES) WAS IMPLANTED AND A COVERED STENT PLACED INSIDE IT TO SEAL THE PERFORATION. THE PATIENT REQUIRED ADMISSION TO THE INTENSIVE CARE UNIT (ICU) HOWEVER; NO ADDITIONAL INFORMATION WAS PROVIDED ON POST PROCEDURE CARE.

  Patient problems: Perforation of Vessels

  MAUDE report 23857994 ↗
• MalfunctionDec 4, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A 3.0MM SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE. THE IVL BALLOON INFLATED WITHOUT INCIDENT AND WAS PULSED AT 4 ATM FOR AN UNKNOWN NUMBER OF PULSES. FOLLOWING IVL, THE BALLOON DID NOT DEFLATE AS EXPECTED. THE BALLOON WAS REMOVED THROUGH THE GUIDE CATHETER WITHOUT DEFLATING AND SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS WHICH WERE RESOLVED FOLLOWING THE REMOVAL OF THE CATHETER. THERE WAS NO REPORTED HARM TO THE PATIENT. A 2ND CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE IVL PROCEDURE. IT WAS NOTED THAT THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Insufficient Information

  MAUDE report 23723380 ↗
• MalfunctionDec 3, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; 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 120 IVL PULSES WERE SUCCESSFULLY DELIVERED. IT WAS REPORTED THAT THE IVL BALLOON WAS HAVING GREAT DIFFICULTY DEFLATING AFTER TREATMENT WHICH WAS OBSERVED AT THE TREATMENT SITE PRIOR TO ATTEMPTING TO WITHDRAW THE IVL CATHETER FROM THE GUIDE CATHETER. ON REMOVAL OF THE IVL CATHETER FROM THE PATIENT, THE BALLOON WAS INTACT BUT NOTED TO BE PARTIALLY INFLATED. AFTER DISCUSSION WITH THE PHYSICIAN, THE BALLOON WAS CONFIRMED TO BE HOLDING PRESSURE AND THERE WERE NO FUNCTIONAL ISSUES WITH THE DEVICE OR WITH IVL THERAPY DELIVERY. THE CATHETER WAS DELIVERED OVER A SION BLUE WIRE USING A 7 FR GUIDE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711433 ↗