Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL8060Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00195451000287), received between Jun 30, 2023 and Jun 29, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 14 most recent of 14 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# 3015053858-2026-00066) 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 25661509 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE COMMON FEMORAL ARTERY (CFA). A BALLOON RUPTURE WAS REPORTED, BUT THE TIMING OF THE RUPTURE AND THE NUMBER OF IVL PULSES DELIVERED ARE UNKNOWN. WHEN REMOVING THE WIRE, IT BECAME CAUGHT IN THE IVL BALLOON CATHETER AND DUE TO THE MANIPULATION, A PART OF THE IVL CATHETER TORE OFF. IT IS UNKNOWN WHETHER THERE WERE ANY FRAGMENTS THAT FELL INSIDE THE PATIENT. A NEW IVL CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709635 ↗
• InjuryAug 13, 2025Difficult to Remove; Difficult to Remove

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. AFTER SUCCESSFUL INSERTION OF THE CATHETER IN THE THIGH, THE DEFLATED DEVICE COULD NO LONGER BE RETRACTED VIA A 7F SHEATH. TO COMPLETE THE TREATMENT, A NEW 7F SHEATH HAD TO BE INSERTED. THIS WAS SUCCESSFUL USING A BODY WIRE, BUT THE BALLOON CATHETER MAY HAVE RUPTURED THE VESSEL, RESULTING IN A PALPABLE HEMATOMA FORMING IN THE FINAL MINUTES OF THE PROCEDURE. THE USE OF A SUTURE CLOSURE SYSTEM WAS UNABLE TO ADEQUATELY CLOSE THE VESSEL. THE SUBSEQUENT COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY REVEALED A LARGE RETROPERITONEAL HEMATOMA. THE PATIENT BECAME INCREASINGLY UNSTABLE OVER A SHORT PERIOD OF TIME AND REQUIRED EMERGENCY SURGERY. THE PROCEDURE WAS UNEVENTFUL UNTIL THE IVL CATHETER MALFUNCTIONED. IT WAS REPORTED THAT THE NEGATIVE OUTCOME WAS DIRECTLY ATTRIBUTABLE TO THE COMPLICATION WITH THE SHOCKWAVE CATHETER. THE PATIENT STATED THAT THE PATIENT HAD A FULL RECOVERY POST-SURGERY.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 22799667 ↗
• InjuryMar 27, 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 TO TREAT A PATIENT WITH SEVERE CALCIFIED ILIAC ARTERY DISEASE. THE IVL CATHETER 300 SUCCESSFULLY DELIVERED 300 PULSES. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT COMMON ILIAC ARTERY PERFORATED, LEADING TO A SIGNIFICANT DROP IN ARTERIAL BLOOD PRESSURE AND NECESSITATING INTUBATION. THE PHYSICIAN DEPLOYED COVERED STENTS EMERGENTLY TO ADDRESS THE PERFORATION. THE EXACT CAUSE OF THE PERFORATION IS UNCERTAIN, WITH POTENTIAL FACTORS INCLUDING BALLOON INFLATION AGAINST A CALCIFIED LESION OR SHEATH ADVANCEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS INTUBATED BUT OTHERWISE STABLE. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE AND DISCHARGED THE FOLLOWING DAY WITH NO ADDITIONAL SEQUELAE.

  Patient problems: Hematoma; Perforation

  MAUDE report 21715646 ↗
• MalfunctionDec 26, 2024Detachment 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 ILIAC ARTERIES. IT IS UNKNOWN HOW MANY PULSES WERE DELIVERED. A KINK OCCURRED DURING REMOVAL OF THE CATHETER, NOT DURING ADVANCEMENT OR PREPARATION. THE EXACT LOCATION OF THE KINK RELATIVE TO THE HUB OR STRAIN RELIEF IS UNKNOWN. RESISTANCE WAS ENCOUNTERED UPON IVL DEVICE REMOVAL AND DETACHMENT OF THE BALLOON OCCURRED WHILE REMOVING THE IVL CATHETER FROM INSIDE OF THE SHEATH. THERE WAS NO BALLOON LOSS OF PRESSURE, AND THE BALLOON WAS FULLY DEFLATED BEFORE REMOVAL. THE SHEATH WAS THEN REMOVED FROM THE PATIENT, AND THE IVL CATHETER WAS RETRIEVED. THE SIZE AND DETAILS OF THE DETACHED COMPONENT ARE UNKNOWN. A NEW SHEATH WAS REINSERTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024052 ↗
• MalfunctionNov 11, 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 USED TO TREAT A LESION IN THE ILIAC ARTERIES. 150 PULSES WERE DELIVERED. DURING WITHDRAWAL, THERE WAS DIFFICULTY GETTING THE CATHETER OUT OF THE SHEATH. WITH INCREASED EFFORT, THE CATHETER TORE OFF IN THE SHEATH AND COULD ONLY BE REMOVED WITH THE SHEATH IN TWO PIECES. 15 CM OF THE CATHETER WAS DETACHED AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW SHEATH WAS THEN INSERTED, AND THE PROCEDURE WAS COMPLETED WITH A SECOND IVL DEVICE OF THE SAME SIZE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652647 ↗
• MalfunctionAug 23, 2024Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. THE IVL CATHETER DELIVERED 247 PULSES. AFTER DELIVERING THE DESIRED PULSES, THE PHYSICIAN INFLATED THE BALLOON UP TO THE RATED BURST PRESSURE (RBP) OF 10 ATM AND THE BALLOON RUPTURED. THE PHYSICIAN WAS ADVISED THAT THE NOMINAL PRESSURE WAS 6 ATM AND THE TREATMENT PRESSURE WAS 4 ATM. IT IS UNKNOWN WHY THE BALLOON WAS EXPANDED TO 10 ATM. WHEN THE BALLOON RUPTURED, THE PHYSICIAN PULLED THE BALLOON BACK BEFORE PULLING NEGATIVE ON THE INDEFLATOR. RESISTANCE WAS NOTED WHEN PULLING BACK THE DEVICE INTO THE SHEATH. THE PHYSICIAN THEN ADVANCED IT FORWARD AND PULLED NEGATIVE ON THE BALLOON. WHEN THE PHYSICIAN TRIED TO REMOVE THE BALLOON FROM THE BODY, IT WAS NOT MOVING THROUGH THE SHEATH. THE BALLOON THEN HAD TO BE REMOVED WITH THE ENTIRE SHEATH AND OUT IN A NEW ONE. THE PATIENT WAS UNHARMED, A SIGNIFICANT AMOUNT OF TIME WAS ADDED TO THE CASE BECAUSE THEY HAD TO SNARE THE WIRE INTO THE OTHER SHEATH IN ORDER TO GET A NEW WIRE UP AND SUCCESSFULLY REMOVE THE SHEATH TO GET THE BALLOON OUT. THE PROCEDURE WAS COMPLETED BY CUTTING THE SHOCKWAVE CATHETER CLOSE TO THE SHEATH ENTRANCE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050447 ↗
• MalfunctionAug 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 USED TO TREAT A LESION IN THE ILIAC ARTERIES. THE IVL BALLOON RUPTURED AFTER 30 PULSES WERE DELIVERED. THERE WAS DIFFICULTY IN REMOVING THE DEVICE. THE DISTAL PART OF THE BALLOON REMAINED STUCK IN THE ARTERY. DURING WITHDRAWAL, THE GUIDEWIRE WITH THE EMITTERS AND PART OF THE BALLOON DETACHED.. THE PATIENT WAS THEN PUT TO SLEEP, AND THE INTRODUCER WAS REMOVED WITH THE CATHETER AFTER SEVERAL ATTEMPTS WITH A SCALPEL. ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH DILATATION AND STENTS. THERE WAS NO HARM REPORTED, AND THE PATIENT IS IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968021 ↗
• MalfunctionJun 25, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERY. THE PHYSICIAN SUCCESSFULLY TREATED THE LEFT ILIAC ARTERY WITH 150 PULSES. THE DEVICE WAS REMOVED FROM THE SHEATH AND REINTRODUCED THROUGH THE SECOND SHEATH ON THE PATIENT'S RIGHT SIDE, AND 150 PULSES WERE DELIVERED IN THE RIGHT ILIAC ARTERY. FOLLOWING IVL TREATMENT, THE IVL BALLOON WAS UNABLE TO DEFLATE COMPLETELY, REMAINING PARTIALLY INFLATED IN THE PATIENT'S ILIAC. THE PHYSICIAN WAS NOT ABLE TO REMOVE THE DEVICE THROUGH THE SHEATH, THEREFORE, THE INTRODUCER SHEATH AND IVL CATHETER HAD TO BE REMOVED TOGETHER. ALL DEVICE COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. DUE TO RISK FOR ENLARGEMENT OF THE INITIAL PUNCTURE POINT IN THE FEMORAL FOLLOWING REMOVAL OF THE IVL CATHETER, AN 11F INTRODUCER WAS PLACED FOR FEMORAL SEALING AND CONTINUATION OF THE INITIAL PROCEDURE. AT THE END OF THE PROCEDURE, IT WAS NECESSARY TO APPLY PROGLIDES AND A SAFEGUARD DRESSING DUE TO THE INCREASED RISK OF BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607022 ↗
• InjuryMay 24, 2024Difficult to Remove; Difficult to Remove

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE THROUGH THE 7F INTRODUCER SHEATH. THE PHYSICIAN HAD TO REMOVE THE INTRODUCER SHEATH AT THE SAME TIME AS THE CATHETER. DUE TO A HOLE IN THE 7F SHEATH, BLEEDING OCCURRED. AS THE 7F SHEATH ALSO HAD TO BE REMOVED AND THE PHYSICIAN HAD A .014" WIRE IN THE VESSEL, BLEEDING AND HEMATOMA OCCURRED AROUND THE PUNCTURE SITE. AS OF THE DATE OF THIS REPORT, THE TREATMENT OF THE HEMATOMA IS UNKNOWN AND THE STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19397778 ↗
• MalfunctionMay 14, 2024Detachment 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 ILIAC ARTERIES. THE PHYSICIAN SUCCESSFULLY DELIVERED 240 PULSES. WHILE ATTEMPTING TO REMOVE THE IVL CATHETER OVER THE 300CM .014" GRAND SLAM GUIDEWIRE THROUGH THE 7F PINNACLE SHEATH, THE BALLOON DETACHED FROM THE SHAFT OF THE IVL CATHETER. THE PHYSICIAN THEN REMOVED THE SHEATH AND FOUND THE DETACHED BALLOON WAS NOT IN THE SHEATH. THE PHYSICIAN THEN PULLED THE GRANDSLAM GUIDEWIRE BACK SLOWLY AND THE BALLOON WAS REMOVED SAFELY OVER THE GRANDSLAM GUIDEWIRE. A SLENDER SHEATH WAS THEN REINSERTED AND TAVR PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315857 ↗
• MalfunctionDec 18, 2023Difficult to Remove; Material Separation; Detachment of Device or Device Component; Difficult to Remove; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION LOCATED IN THE ILIAC LESION. 300 PULSES WERE SUCCESSFULLY DELIVERED. AT THE END OF THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON BECAME DETACHED WITHIN THE 6 FR SHEATH WHILE THE SHEATH WAS STILL INSIDE THE PATIENT. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BALLOON WHEN REMOVING THE SHEATH. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345945 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT IN HER 60'S, UNDERWENT A DISTAL AORTIC TOTAL OCCLUSION PROCEDURE TO TREAT THE RIGHT AND LEFT ILIAC ARTERIES USING THE SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. THE IVL SUCCESSFULLY DELIVERED 150 PULSES IN THE LEFT ILIAC. AFTER THE IVL BALLOON DELIVERED 150 PULSES IN THE RIGHT ILIAC, A DISTAL EMBOLISM WAS OBSERVED. ACCORDING TO THE PHYSICIAN, THE EMBOLISM WAS LOCATED ON TOP OF THE OCCLUSION AND IVL BALLOON WAS UNABLE TO REMOVE THE EMBOLI. THE PATIENT WAS TAKEN TO SURGERY AND UNDERWENT THROMBECTOMY AND ENDOVASCULAR ANEURYSM REPAIR (EVAR). POST SURGERY, THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR A WEEK. THERE WAS NO REPORT OF IVL CATHETER MALFUNCTION.

  Patient problems: Embolism/Embolus

  MAUDE report 18116349 ↗
• InjuryJun 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE TO TREAT THE LEFT EXTERNAL ILIAC WITH A SHOCKWAVE M5+ PERIPHERAL LITHOTRIPSY (IVL) CATHETER. AFTER THE IVL SUCCESSFULLY DELIVERED 210 PULSES, IT WAS REMOVED FROM THE PATIENT'S ANATOMY. THE IVL BALLOON WAS RE-PREPPED AND WHILE FLUSHING THE GUIDEWIRE PORT, THE BALLOON INFLATED CAUSING A CONNECTION BETWEEN THE BALLOON AND GUIDEWIRE PORTS. ANOTHER IVL WAS PREPARED AND USED, AND IT SUCCESSFULLY DELIVERED AN ADDITIONAL 100 PULSES. AFTER THE IVL PROCEDURE, THE PHYSICIAN USED AN 8.0MM ANGIOPLASTY BALLOON WHICH WAS PRESSURIZED TO 12 ATMOSPHERES TO POST DILATE THE ILIAC ARTERY. ON FIRST INFLATION, THE BALLOON RUPTURED CAUSING A PERFORATION. THE PHYSICIAN IMMEDIATELY USED A COVERED STENT TO CONTROL THE BLEEDING. HOWEVER, THE PATIENT EXPERIENCED RETROPERITONEAL BLEED AND THE VASCULAR SURGEON HAD TO PERFORM A PERI-PROCEDURE CUTDOWN TO INSERT A DRAINAGE. THE PATIENT IS REPORTED TO BE STABLE AND IS DOING WELL. THE PHYSICIAN AND THE VASCULAR SURGEON STATED THAT THE USE OF THE ANGIOPLASTY BALLOON WAS CAUSAL TO THE ILIAC ARTERY PERFORATION AND NOT THE IVL. THE COMMENT MADE BY THE PHYSICIAN WAS THAT WITHOUT THE

  Patient problems: Perforation; Retroperitoneal Hemorrhage

  MAUDE report 17239840 ↗