Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL080030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00195451000386), received between Apr 2, 2025 and Jun 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026No Apparent Adverse Event; Device Handling Problem

  IT WAS REPORTED THAT A SHOCKWAVE L6 PERIPHERAL IVL CATHETER LABELED DEVICE POUCH (L6IVL080030, LOT 01A251024A) (MDR# ) WAS FOUND PACKAGED INSIDE A SHOCKWAVE M5+ PERIPHERAL IVL CATHETER CARTON (M5PIVL8060, LOT 82352170) (MDR# 3015053858-2026-00065). THE PHYSICIAN INTENDED TO USE A SHOCKWAVE M5+ 8.0X60 MM DEVICE DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC. THE SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER LABELED CARTON CONTAINED A SHOCKWAVE L6 8.0X30 MM DEVICE POUCH. THE INCORRECT SHOCKWAVE L6 DEVICE WAS NOTICED DURING THE PROCEDURE AT THE FIRST INFLATION AND WAS USED IN THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EVENTS, AND THE PATIENT WAS FINE. NO OTHER SHOCKWAVE DEVICES WERE USED DURING THE PROCEDURE. THE COMPANY REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. THE CUSTOMER DISCARDED EVERYTHING INCLUDING BOTH THE CARTON AND THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661501 ↗
• MalfunctionMar 26, 2026Off-Label Use; Detachment of Device or Device Component; Difficult to Advance

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERY. IT WAS REPORTED THAT THE IVL BALLOON SHEARED OFF THE CATHETER UPON REINSERTION OF THE DEVICE, WHICH IS OFF-LABEL PER THE DEVICE INSTRUCTIONS FOR USE. THE DISTAL IVL BALLOON SEGMENT WAS NOTED TO BE ADJACENT TO AN INTERNAL ILIAC STENT AND THE IVL BALLOON DETACHED INSIDE THE PATIENT. THE DETACHED BALLOON FRAGMENT WAS RETRIEVED BY ADVANCING A 7FR SHEATH, FOLLOWED BY A 5FR SLENDER, OVER THE BALLOON FRAGMENT WHILE WORKING OVER A 0.018" WIRE. THE SHEATH WAS ADVANCED FURTHER TO CAPTURE THE MATERIAL, AND SIGNIFICANT FORCE WAS REQUIRED TO PASS THE SHEATH OVER AND EXTRACT THE FRAGMENT. NO ADDITIONAL CONTAINMENT OR INTERVENTION WAS NEEDED FOLLOWING SUCCESSFUL REMOVAL OF THE IVL DEVICE COMPONENTS. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE, AND NO ADDITIONAL PATIENT SEQUELAE REPORTED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701688 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THREE HUNDRED IVL PULSES WERE DELIVERED AND THE TREATMENT WAS COMPLETED. WHILE WITHDRAWING THE DEVICE THROUGH A 7F COOK ANSEL SHEATH AFTER CROSSING THE AORTA, THE BALLOON SEPARATED FROM THE EMITTERS AT THE HUB OF THE BLUE STRAIN RELIEF. THE OUTER CLEAR PLASTIC SHEATH SHEARED OFF COMPLETELY AT ITS ATTACHMENT SITE. A PART OF THE DETACHED PORTION REMAINED IN THE PATIENT WHILE APPROXIMATELY 5 CM PROTRUDED FROM THE SHEATH. THERE WAS NO FRAGMENT THAT MIGRATED FREELY INTO THE PATIENT. THE EMITTERS AND MAIN CATHETER SHAFT WERE RETRIEVED FIRST; THE BALLOON WAS THEN REMOVED SEPARATELY FROM THE SHEATH AND RETRIEVED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384338 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED IN A PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY. IT WAS REPORTED THAT THE OUTER SHAFT OF THE IVL BALLOON CATHETER SEPARATED FROM THE INNER SHAFT DURING DEVICE REMOVAL; THE SEPARATED COMPONENT WAS SNARED, AND ALL DEVICE COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785544 ↗
• MalfunctionDec 3, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. A TOTAL OF 150 IVL PULSES WERE DELIVERED. AFTER FULLY DEFLATING THE BALLOON AND WHILE WITHDRAWING THE DEVICE THROUGH A 7-FRENCH SHEATH, THE BALLOON BECAME STUCK AND DETACHED. THE DETACHMENT WAS VISIBLE AT THE DISTAL END OF THE CATHETER. NO PATIENT HARM WAS REPORTED. THE DETACHMENT OF THE BALLOON OCCURRED INSIDE THE PATIENT AND WITHIN THE CATHETER. ALL COMPONENTS OF THE DEVICE WERE REMOVED AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706122 ↗
• MalfunctionOct 16, 2025Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate; Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A STENOTIC LESION IN THE LEFT COMMON ILIAC ARTERY. A TOTAL OF 300 IVL PULSES WERE SUCCESSFULLY DELIVERED. UPON REMOVAL OF THE DEVICE, THE PHYSICIAN OBSERVED SIGNIFICANT TENSION COMING OUT OF THE SHEATH. THE PHYSICIAN THEN FIXED AN EMPTY SYRINGE TO THE INFLATION PORT AND PULLED NEGATIVE. THE TENSION WAS PERSISTENT, AND THE PHYSICIAN PULLED THE CATHETER OUT WITH EXTREME FORCE. AN AUDIBLE SNAPPING SOUND WAS HEARD, AND THE CATHETER SHAFT WAS REMOVED. HOWEVER, THE DISTAL PORTION OF THE CATHETER SHAFT WITH THE DISTAL MARKER BAND AND ALL BLUE MATERIAL WAS STUCK IN THE BODY AND FIXED TO THE .018 COMMAND WIRE. DESPITE MULTIPLE ATTEMPTS TO PULL THIS PORTION OF THE DEVICE OUT OF THE SHEATH, IT WAS UNSUCCESSFUL. A CATHETER WAS THEN USED TO ADVANCE THIS PORTION OF THE DEVICE UP AND OVER THE ILIAC ARCH INTO THE RIGHT COMMON FEMORAL ARTERY. A SURGICAL CUTDOWN OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED TO RETRIEVE THE FRAGMENT, WHICH WAS SUCCESSFULLY REMOVED. THE DETACHED BALLOON MATERIAL MEASURED APPROXIMATELY 30 MM IN LENGTH BUT WAS DAMAGED AND CRUMPLED, WITH A PROFILE OR DIAMETER CLOSE TO 1 CM. NO ADDITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318834 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. 300 IVL PULSES WERE DELIVERED AT 3 ATM. THE PROCEDURE WAS SUCCESSFUL, AND THE CATHETER COMPLETELY SEPARATED UPON REMOVAL FROM THE 7FR SHEATH. THERE WAS NO KINKING OBSERVED ON THE DEVICE DURING THE PROCEDURE. THE BALLOON WAS FULLY DEFLATED AND ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED WITHOUT THE NEED FOR ADDITIONAL DEVICES. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. A COVERED STENT WAS PLACED AS ORIGINALLY PLANNED, AND BALLOON ANGIOPLASTY WAS PERFORMED AFTER THE STENT WAS DEPLOYED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753423 ↗