Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL5060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00195451000232), received between Nov 9, 2023 and Nov 18, 2025 — classified as 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT FROM A RIGHT PEDAL APPROACH USING A 6 FR SHEATH, THE IVL DEVICE WAS ADVANCED OVER A 300 CM COMMAND WIRE TO THE COMMON FEMORAL ARTERY (CFA) FOR REPAIR OF AN OCCLUSION EXTENDING FROM THE SFA TO THE POPLITEAL ARTERY. A TOTAL OF 300 PULSES WERE DELIVERED AT 4 ATM BEGINNING AT THE CFA AND PROGRESSING DISTALLY TOWARD THE POPLITEAL ARTERY. UPON REMOVAL OF THE IVL DEVICE, RESISTANCE WAS ENCOUNTERED; THE DEVICE WAS WITHDRAWN FROM THE SHEATH AND DISCARDED. ATTEMPTS TO DELIVER A 5X200 DRUG-COATED BALLOON (DCB) WOULD NOT CROSS PAST THE POPLITEAL ARTERY. A SMALLER 3X40 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON (PTA) BALLOON WAS INTRODUCED BUT ALSO STRUGGLED TO CROSS THE LESION. THE DISCARDED IVL DEVICE WAS OBSERVED, AND IT WAS NOTED THAT THE NYLON BALLOON MATERIAL HAD STRIPPED FROM THE IVL DEVICE. USING A 2X20 CORONARY BALLOON, THE EMBOLIZED IVL BALLOON MATERIAL WAS SUBSEQUENTLY RECOVERED. NO NYLON MATERIAL WAS OBSERVED WITHIN THE VASCULAR LUMEN ON ANGIOGRAPHY OR INTRAVASCULAR ULTRASOUND (IVUS). THE PHYSICIAN PERFORMED SERIAL BALLOONING

  Patient problems: Embolism/Embolus

  MAUDE report 23589716 ↗
• InjuryJan 31, 2024Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN M5+ PERIPHERAL IVL CATHETER WAS USED WITH A 300CM ABBOTT COMMAND ES WIRE TO TREAT A CALCIFIED CAROTID LESION. THE DEVICE ADMINISTERED 120 PULSES WITHOUT ANY DOCUMENTABLE ISSUE. THE PATIENT SUFFERED A HEMORRHAGIC STROKE AFTER THE PROCEDURE WHICH IS ATTRIBUTED TO THE USE OF THE GUIDEWIRE AS WELL AS THE OFF-LABEL USE OF THE IVL CATHETER. TO DATE, THE PATIENT IS RECOVERING IN REHAB AND HAS HAD A CRANIOTOMY.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 18619434 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN 84-YEAR-OLD MALE PATIENT UNDERWENT A LEFT LEG INTERVENTION TO TREAT A DISEASED SUPERFICIAL FEMORA ARTERY (SFA). THE MID TO DISTAL ARTERY WAS REPORTED TO HAVE SEVERE CALCIUM. THE VASCULAR SURGEON USED A DIAMONDBACK 360¿ CORONARY ORBITAL ATHERECTOMY SYSTEM TO PREPARE THE LESION. IT WAS FOLLOWED BY ADVANCING THE SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER IN THE SFA. AT ONCE, THE PATIENT EXPERIENCED BASELINE RHYTHM ATRIAL FIBRILLATION (AFIB). AFTER THE IVL CATHETER DELIVERED ONE CYCLE OF PULSES, THE ANESTHESIOLOGIST CALLED OUT THAT THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (V-TACH). REPORTEDLY, THE VASCULAR SURGEON DIDN'T THINK IT WAS RELATED TO IVL. THE BALLOON WAS DEFLATED AND REINFLATED TO START THE SECOND CYCLE. ONCE THE SECOND CYCLE BEGAN THE V-TACH REAPPEARED. THE IVL TREATMENT WAS STOPPED AND AFTER THE IVL CATHETER WAS REMOVED, THE PATIENT REVERTED TO AFIB WITHIN SECONDS WITHOUT CHEMICAL OR ELECTRICAL CARDIOVERSION. REPORTEDLY, THE VASCULAR SURGEON DID NOT TREAT THE AFIB EXCEPT PROVIDE INTRAVENOUS UNFRACTIONATED HEPARINIZATION THAT IS USED FOR MOST CASES. THE PATIENT WAS ADMITTED OVERNIGHT AT THE HOSPITAL AND WAS DISCHARGED THE

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 18107259 ↗