Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL6060Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00195451000256), received between Feb 6, 2023 and Mar 25, 2026 — classified as 1 death, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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.

• MalfunctionMar 25, 2026Difficult to Remove; Deformation Due to Compressive Stress; 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). A TOTAL OF 300 IVL PULSES WERE DELIVERED. DURING DEVICE WITHDRAWAL, RESISTANCE WAS ENCOUNTERED WITH THE IVL BALLOON AT THE ORIGIN OF THE PEDAL SHEATH. THE PHYSICIAN TUGGED AND SEPARATED THE BALLOON FROM THE SHAFT. THE PHYSICIAN THEN REMOVED THE SHEATH, AND THE REMAINDER OF THE SHOCKWAVE DEVICE COMPLETELY. A NEW SHEATH WAS INTRODUCED, AND THE CASE WAS COMPLETED WITH STENT PLACEMENT IN THE SFA. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691714 ↗
• MalfunctionOct 16, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A SHOCKWAVE M5+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. THE IVL PROCEDURE WAS COMPLETED, ALTHOUGH THE EXACT NUMBER OF PULSES DELIVERED IS UNKNOWN. AFTER DEFLATING THE BALLOON, ATTEMPTS WERE MADE TO REMOVE THE IVL CATHETER THROUGH THE SHEATH; HOWEVER, THE BALLOON COULD NOT BE REMOVED DESPITE MULTIPLE EFFORTS TO PULL NEGATIVE AGAINST THE BALLOON. ULTIMATELY, THE SHAFT OF THE IVL CATHETER DETACHED, LEAVING THE CLEAR BALLOON INSIDE THE SHEATH. IT WAS DECIDED TO REMOVE THE SHEATH WITH THE BALLOON STILL INSIDE AND TO RE-SHEATH THE PATIENT WITH A NEW SHEATH. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318833 ↗
• DeathJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED WAS USED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE SHOCKWAVE CATHETER DELIVERED 300 PULSES AT A PULSE PRESSURE OF 4ATM SUCCESSFULLY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATIONS FOLLOWING STENT DELIVERY. IT WAS REPORTED THAT THE SHOCKWAVE DEVICE HAD NO IMPACT ON THE PATIENT'S COMPLICATIONS. ACCORDING TO THE MANAGEMENT TEAM, THE PATIENT DEATH OCCURRED POST PROCEDURE, AFTER BEING TRANSFERRED TO THE HEART CENTER. THERE WAS NO ADDITIONAL INFORMATION KNOWN AND/OR PROVIDED REGARDING THE EVENT. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND PATIENT DEATH OCCURRED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 22325626 ↗
• MalfunctionJun 13, 2025Detachment of Device or Device Component; 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). ALL SHOCKWAVE PULSES WERE USED. AFTER THE PROCEDURE, THE PHYSICIAN FOUND THAT THE OUTER TRANSPARENT BALLOON ON THE CATHETER DETACHED FROM THE EMITTER WIRE AND THE BALLOON WAS STUCK ON THE 6F SUPER-ARROW FLEX SHEATH. THE DETACHMENT OCCURRED DURING THE REMOVAL OF THE SHOCKWAVE CATHETER AFTER 10 CYCLES WERE COMPLETED. DETACHMENT WAS ONLY SPOTTED WHEN AN IMAGING RUN WAS DONE, AND THE PHYSICIANS REALIZED THAT THE SHEATH WAS SLANTED ON THE ANGIOGRAM. THEY HAD TO COMPLETELY REMOVE THE SHEATH IN WHICH THEY FOUND THAT THE BALLOON WAS DETACHED AND STUCK INSIDE THE SHEATH. THERE WAS A SLIGHT TUG OF THE CATHETER DURING REMOVAL. THERE WAS NO BALLOON RUPTURE OR LOSS OF PRESSURE PRIOR TO THE INABILITY TO REMOVE THE DEVICE. THE BALLOON WAS FULLY DEFLATED PRIOR TO THE REMOVAL. THERE WAS NO REPORTED PATIENT HARM, AND THE PATIENT IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205484 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; 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). THE BALLOON TORE DURING ADVANCEMENT THROUGH THE SHEATH. THE DETACHMENT OCCURRED INSIDE THE PATIENT, BUT THE DETACHED COMPONENT WAS SUCCESSFULLY RETRIEVED USING A BALLOON THAT DEGLOVED THE CATHETER, LEAVING NO FRAGMENTS BEHIND. THERE WERE NO IVL PULSES THAT WERE DELIVERED, AND THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073408 ↗
• MalfunctionNov 7, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; 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) AND THE POPLITEAL ARTERY. DURING THE PROCEDURE, THE BALLOON RUPTURED, THOUGH SPECIFIC DELIVERY INFORMATION WAS NOT PROVIDED. WHILE ATTEMPTING TO REMOVE THE DEVICE THROUGH THE SHEATH, A BREAKAGE OCCURRED. THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN THE BALLOON BECAME LODGED IN THE SHEATH. TO RESOLVE THE ISSUE, BOTH THE SHEATH AND CATHETER WERE REMOVED TOGETHER, AND THE SHEATH WAS UPSIZED TO AN 8 FRENCH (8FR) FOR SUCCESSFUL COMPLETION OF THE PROCEDURE. NO FRAGMENTS WERE RETAINED IN THE PATIENT. TO DATE, NO PATIENT SEQUELAE HAS OCCURRED AS A RESULT OF THE BALLOON RUPTURE/DETACHMENT OF BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633076 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE M5 PLUS INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERIES (SFA). THE CATHETER WAS INTRODUCED INTO THE BODY WITH NO RESISTANCE AND SUCCESSFULLY DELIVERED 300 PULSES. DURING WITHDRAWAL, IT WAS NOTED THAT THE 6FR TERUMO SLENDER SHEATH BECAME SEVERELY KINKED SECONDARY TO THE PATIENT BENDING THEIR LEG AT THE POPLITEAL ACCESS SITE, CAUSING THE IVL CATHETER TO GET STUCK INSIDE THE SHEATH. THE PHYSICIAN THEN PULLED THE CATHETER WITH FORCE, CAUSING THE CATHETER SHAFT TO DETACH FROM THE BALLOON DURING REMOVAL FROM THE SHEATH, LEAVING THE DETACHED BALLOON PARTIALLY IN THE SHEATH. IT WAS CONFIRMED THAT THE DETACHED COMPONENTS WERE CONTAINED IN THE SHEATH. THE SHEATH AND BALLOON WERE THEN EXCHANGED FOR A NEW 6FR SLENDER SHEATH. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150168 ↗
• MalfunctionJul 11, 2024Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). 300 PULSES WERE SUCCESSFULLY DELIVERED. UPON ATTEMPTS TO WITHDRAW THE IVL CATHETER FROM THE PATIENT, THE DEVICE BECAME STUCK ON THE 7MM SPIDER WIRE. THERE WERE MULTIPLE ATTEMPTS TO RETRIEVE THE CATHETER FROM THE WIRE. THE WIRE AND THE CATHETER WERE REMOVED TOGETHER FROM THE PATIENT. DURING WITHDRAWAL, THE IVL CATHETER BROKE. IT IS UNKNOWN WHERE THE BREAKAGE OCCURRED AND WHETHER THERE WAS COMPLETE DEVICE SEPARATION. IT WAS CONFIRMED THAT NO DEVICE FRAGMENT FELL INSIDE THE PATIENT. FINAL ANGIOGRAMS DEMONSTRATED AN EXCELLENT RESULT FOR THE PATIENT WITHOUT ANY ISSUE OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724172 ↗
• MalfunctionMar 12, 2024Difficult 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 BEING USED TO TREAT AN UNKNOWN LESION. AFTER SUCCESSFULLY DELIVERY OF IVL PULSES, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER FROM THE PATIENT AND ENCOUNTERED DIFFICULTIES. USING FORCE, THE BALLOON BECAME STUCK IN THE 6FR PINNACLE INTRODUCER SHEATH, LEADING TO BALLOON DETACHMENT FROM THE IVL CATHETER. THE DETACHED IVL BALLOON REMAINED CONTAINED WITHIN THE 6F SHEATH, AND THE SHEATH AND DETACHED BALLOON WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE SHEATH WAS CHANGED FOR A NEW SHEATH, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT SEQUELAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888356 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE M5 PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT AN ABOVE THE KNEE LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. DURING THE IVL TREATMENT, IT WAS NOTICED THAT THE PATIENT HAD GONE INTO SUPRAVENTRICULAR TACHYCARDIA (SVT). AFTER THE PHYSICIAN STOPPED THE PROCEDURE, THE PATIENT'S SINUS RHYTHM RETURNED TO NORMAL. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED WITH THE ADVERSE EVENT.

  Patient problems: Arrhythmia

  MAUDE report 18705168 ↗
• MalfunctionSep 15, 2023Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO TREAT A HEAVILY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. AFTER THE SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON SUCCESSFULLY DELIVERED 30 PULSES, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON WITH AN INDEFLATOR. HOWEVER, IT WAS OBSERVED ON ANGIOGRAM THAT CONTRAST WAS STILL PRESENT IN THE BALLOON AFTER MULTIPLE NEGATIVE PULLS. THE PHYSICIAN ENDED UP DEFLATING THE BALLOON WITH A LARGE SYRINGE. THE BALLOON WAS REPOSITIONED SLIGHTLY TO THE PROXIMAL LESION AND WAS INFLATED AGAIN. ANOTHER ROUND OF TREATMENT WAS GIVEN AND AGAIN, BALLOON DEFLATION PROVED DIFFICULT, SO THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL CATHETER OVER THE 0.014" GUIDEWIRE. IT WAS OBSERVED ON AN ANGIOGRAM THAT A COMPLETE SEPARATION OF THE DISTAL BALLOON MARKER AND THE DISTAL EMITTER OCCURRED, SO THE CATHETER WAS PULLED BACK WITH EXTREME CAUTION. ONCE THE CATHETER HAD BEEN REMOVED ENTIRELY FROM THE PATIENT'S BODY, THERE WAS GREAT DIFFICULTY REMOVING IT FROM THE END OF THE 0.014" WIRE. THE PHYSICIAN CUT THROUGH A PORTION OF THE BODY OF THE CATHETER ONCE THE PROXIMAL EN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760924 ↗
• MalfunctionFeb 27, 2023Off-Label Use; Difficult to Remove; Detachment of Device or Device Component; Off-Label Use; Difficult to Remove; Detachment of Device or Device Component

  A SHOCKWAVE M5+ INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A LESION LOCATED IN THE POPLITEAL ARTERY. THERE WAS DIFFICULTY CROSSING SO THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL DEVICE USING EXCESSIVE FORCE. AFTER THE DEVICE WAS REMOVED, THE BALLOON WAS FOUND TO HAVE DETACHED FROM THE CATHETER AND WAS FIRMLY LODGED INSIDE THE TIP OF THE 6F FLEXOR SHEATH. THE PHYSICIAN ALSO REMOVED THE SHEATH AS A UNIT, AND NOTHING REMAINED INSIDE THE PATIENT. ADDITIONALLY, THE PATIENT WAS REPORTED TO HAVE A PRE-EXISTING STENT IMPLANTED IN THE POPLITEAL ARTERY. THE PHYSICIAN DECIDED TO TREAT THE STENTED PORTION BECAUSE THE DISTAL FLOW WAS SUB-OPTIMAL. THE PHYSICIAN WAS AWARE THAT HE WAS USING THE DEVICE OFF-LABEL. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CLINICAL SEQUELAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16447314 ↗
• MalfunctionFeb 6, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IV) CATHETER WAS USED TO TREAT A LESION LOCATED IN THE FEMORAL ARTERY. AFTER THE BALLOON SUCCESSFULLY DELIVERED 270 PULSES, THE PHYSICIAN ATTEMPTED TO PULL OUT THE CATHETER. DURING THE REMOVAL OF THE CATHETER THROUGH THE 6F SHEATH, IT GOT STUCK AND THE BALLOON DETACHED WHILE IT WAS INSIDE THE SHEATH. IT WAS REPORTED THAT NO EXCESSIVE FORCE WAS USED DURING THE REMOVAL OF THE CATHETER. WHEN THE SHEATH WAS FINALLY REMOVED FROM THE PATIENT, THE BALLOON WAS INSIDE AND WAS SUCCESSFULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308124 ↗