Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL4012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00195451000119), received between Aug 17, 2021 and Jun 19, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. THE PATIENT PRESENTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) WITH A 100% OCCLUDED RIGHT CORONARY ARTERY (RCA). PRIOR TO IVL, THEY USED THROMBECTOMY AND BALLOONS. CALCIUM WAS SEEN ON THE INTRAVASCULAR ULTRASOUND (IVUS). WHILE IVL THERAPY WAS BEING DELIVERED, THE PATIENT WENT INTO TORSADES DE POINTES AND VENTRICULAR FIBRILLATION. THE PATIENT WAS SUCCESSFULLY DEFIBRILLATED BACK INTO NORMAL SINUS RHYTHM (NSR) AND THE PROCEDURE WAS COMPLETED WITH A STENT. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Ventricular Fibrillation

  MAUDE report 19570928 ↗
• InjuryNov 10, 2023Failure to Cycle; Off-Label Use; Failure to Cycle; Off-Label Use

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO TREAT A LESION IN THE CARINA BIFURCATION SITE WITHIN THE CORONARY ARTERY WITH A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. ACCORDING TO THE REPORT, THE IVL BALLOON PULSED INSIDE A PRE-EXISTING STENT WHICH IS AN UNAPPROVED INDICATION AND CONSIDERED OFF-LABEL. ACCORDINGLY, THE IVL BALLOON HAD DELIVERED 10 PULSES BEFORE ERROR 88 APPEARED. ALL THE CONNECTIONS WERE RECHECKED AND THE IVL BALLOON WAS RE-PREPPED MULTIPLE TIMES BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A CUTTING BALLOON HOWEVER, THE PATIENT WAS REPORTED TO HAVE DEVELOPED A CLOT AND EXPERIENCED A THROMBOEMBOLIC EVENT. THE CLOT WAS TREATED WITH TIROFIBAN ADMINISTERED INTRAVENOUSLY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND IT IS CURRENTLY DOING WELL.

  Patient problems: Thromboembolism

  MAUDE report 18116590 ↗
• MalfunctionAug 19, 2022Material Rupture

  BALLOON POPPED AFTER 1ST INFLATION TO 4ATM AND TREATMENT. MANUFACTURER RESPONSE FOR SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM, SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER (PER SITE REPORTER) REPORTED TO SALES REP, HE WILL PICK UP AND SENT IN, (B)(6) PO ISSUED FOR REPLACEMENT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257811 ↗
• InjuryJan 4, 2022Material Puncture/Hole; Material Rupture; Sparking; Material Puncture/Hole; Material Rupture; Sparking

  A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A PATIENT WHO UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A LESION AT THE LEFT MAIN (LM), LEFT ANTERIOR DESCENDING (LAD) AND THE CIRCUMFLEX (CX) ARTERIES. IVUS IMAGING SHOWED THERE WAS CALCIFICATION ON THE VESSEL WALLS, AND NO PRESENCE OF PRE-EXISTING STENT(S) WITHIN THE VICINITY OF THE TARGET VESSEL. THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE WHILE TRACKING THE IVL CATHETER TO THE TARGET VESSEL. UPON DELIVERY OF 20 PULSES WITH THE IVL CATHETER, THE PHYSICIAN REPORTED PULSING AT THE CATHETER HUB WHEN THE BUTTON WAS PRESSED TO ACTIVATE IVL. WHEN THE IVL BALLOON WAS IN THE LEFT MAIN, THE BALLOON RUPTURED AND DISSECTION WAS OBSERVED UNDER FLUOROSCOPY AND IVUS; THE DISSECTION GRADE WAS NOT REPORTED. THROMBOSIS WAS ALSO NOTED IN THE LM, LAD, AND CX SO THE PHYSICIAN PERFORMED THROMBECTOMY AND THEN IMPLANTED DRUG-ELUTING STENT (DES) POST IVL PROCEDURE. THE PATIENT HAD PROLONGED HOSPITAL STAY AND WAS DISCHARGED TO HOME 3 DAYS LATER. ADDITIONAL INFORMATION WAS RECEIVED FROM MEDWATCH (B)(4) SUBMITTED BY THE USER FACILITY. IT WAS REPORTED THAT THE PHYSICIAN WAS SHOCKED BY THE IVL BALLOON CATHETE

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 13158177 ↗
• MalfunctionNov 24, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE AREA OF TREATMENT WAS AN OLD RE-STENOSED STENT IN THE OSTIAL/PROXIMAL/MID CIRCUMFLEX ARTERY. IT IS TO BE NOTED THAT THE C2 IVL IS INDICATED ONLY FOR TREATMENT OF DE NOVO ARTERIES AND TREATMENT OF A RE-STENOSED STENT IS OUTSIDE OF THE INSTRUCTIONS FOR USE. THE PROCEDURE WAS DONE THROUGH THE RADIAL APPROACH, 6F GUIDE CATHETER (VODA LEFT 3.5), RUNTHROUGH WIRE. THE LESION WAS PREDILATED WITH A 2.5 X 12 TREK BALLOON. A 4 X 12 C2 CATHETER WAS USED AND 80 PULSES WERE ADMINISTERED TO THE MID/PROX CIRCUMFLEX AREA (IN STENT). ALL PULSES WERE ADMINISTERED AT 4ATM AND THEN THE DEVICE WAS INFLATED TO 10ATM TO DILATE THE AREA OF INTEREST, WHICH IS OUTSIDE THE INSTRUCTIONS FOR USE FOR THE C2 IVL DEVICE. WHEN DEFLATING THE BALLOON THE RADIOLOGY TECH (RT) DID NOT NOTICE ANY BLOOD COMING BACK THROUGH THE SHAFT OR INTO THE INFLATION DEVICE AND THE BALLOON APPEARED TO PERFORM NORMALLY THROUGHOUT USE. UPON REMOVAL OF THE SHOCKWAVE C2 CATHETER, THERE WAS RESISTANCE AS THE BALLOON REACHED THE LEFT MAIN (LM) OSTIUM AND GUIDE CATHETER. THE PHYSICIAN UNSEATED THE GUIDE CATHETER FROM THE LM OSTIUM AND WITHDREW THE C2 CATHETER INTO THE GUIDE CATHETER WHILE IN THE AORTA, WITH SOME RESISTANCE. ONCE THE C2 W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869298 ↗
• MalfunctionAug 17, 2021Material Rupture; Material Rupture

  TWO SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICES WERE USED TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY. INITIALLY, SHOCKWAVE'S C2IVL4012 CATHETER WAS PREPPED AND INSERTED INTO THE PATIENT. IT WAS REPORTED THAT THE DEVICE LOST PRESSURE AFTER DELIVERING 2 PULSES OF IVL THERAPY. SUBSEQUENTLY, A SECOND SHOCKWAVE CATHETER WAS PREPPED AND INSERTED INTO THE PATIENT (C2IVL3512), AND THAT DEVISE WAS ALSO REPORTED TO HAVE LOST PRESSURE AFTER DELIVERING 2 PULSES OF IVL THERAPY. BOTH CATHETERS WERE INFLATED TO 4 ATMOSPHERES AT THE TIME OF IVL DELIVERY. A NON-COMPLIANT (NC) BALLOON WAS THEN USED FOLLOWING THE RUPTURE OF THE SHOCKWAVE DEVICES TO CONTINUE THE CASE. THE PATIENT REPORTED TO EXPERIENCE SYMPTOMS OF HYPOTENSION AND ANGINA, REQUIRING ADDITIONAL PHARMACOLOGICAL THERAPY WITH NOREPINEPHRINE. BASED ON PROVIDED INFORMATION, IT IS UNCLEAR IF THE SYMPTOMS OCCURRED AFTER EITHER THE FIRST OR SECOND IVL BALLOON PRESSURE LOSS. IVUS GUIDED PERCUTANEOUS CORONARY INTERVENTION WAS SUCCESSFULLY COMPLETED ON THE LEFT MAIN BIFURCATION WITHOUT ANY FURTHER COMPLICATIONS. POST PROCEDURE, THE PATIENT WAS STABLE WITH NO ANGINA SYMPTOMS, WITH STABLE BLOOD PRESSURE VALUES. NOREPINEPHRINE WAS NO LONGE

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 12334772 ↗