Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL7060 (UDI 00195451000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00195451000195), received between Oct 27, 2021 and Dec 16, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Difficult to Remove; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  AN M5 IVL PERIPHERAL CATHETER WAS USED ACCESSING THOUGHT THE LEFT FEMORAL ARTERY TO TREAT THE LEFT AND RIGHT ILIAC ARTERY. A BALLOON RUPTURED MAY HAVE OCCURRED AND WHEN REMOVING THE IVL CATHETER FROM THE BODY, DETACHMENT OF THE BALLOON OCCURRED AND WERE UNSUCCESSFUL TO SNARE. THE DETACHED PORTION OF THE IVL CATHETER WAS SUCCESSFULLY TRAPPED WITH A GORE VBX STENT. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED. IT WAS NOTED THAT THE DEVICE WAS INITIALLY USED FOR 120 PULSES, REMOVED FROM THE BODY AND THEN REINSERTED INTO THE BODY FOR FURTHER PULSING THAT CAN CAUSE THE BALLOON TO BE DAMAGED IN THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996614 ↗
• MalfunctionApr 15, 2022Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 IVL CATHETER WAS USED TO TREAT THE RIGHT ILIAC. AFTER 246 PULSES, A BALLOON LOSS OF PRESSURE OCCURRED. CONTRAST HUNG UP IN END OF BALLOON THAT WAS DIFFICULT TO REMOVE. WHEN PULLING THE BALLOON INTO THE SHEATH, THE DISTAL END OF THE BALLOON SEPARATED. THE IVL CATHETER INCLUDING THE SEPARATED PIECE CAME OUT FROM THE SHEATH. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118966 ↗
• MalfunctionMar 29, 2022Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 IVL CATHETER WAS USED TO TREAT AN ILIAC ARTERY. A BALLOON LOSS OF PRESSURE WAS ENCOUNTERED AFTER THE FIRST CYCLE OF PULSES AT 2 ATMOSPHERES. UPON REMOVAL OF THE IVL CATHETER, IT WAS OBSERVED THAT A PART OF THE BALLOON WAS DETACHED INSIDE OF THE PATIENT. THE DETACHED PORTION OF THE BALLOON WAS PINNED BETWEEN THE STENT AND THE ILIAC TO PREVENT MOVEMENT. THE PHYSICIAN BELIEVES THAT THE SHELF OF CALCIUM MAY HAVE CAUGHT THE BALLOON UPON WITHDRAWAL CAUSING THE PARTIAL BALLOON DETACHMENT. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943766 ↗
• MalfunctionMar 29, 2022Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  THIS COMPLAINT IS VIA A MEDWATCH REPORT (UF/IMPORTER REPORT # (B)(4)). A SHOCKWAVE M5 IVL CATHETER WAS USED TO TREAT THE ILIAC ARTERY. THE MAXIMUM BALLOON DILATION THROUGHOUT THE PROCEDURE WAS 8 ATMOSPHERES. UPON COMPLETION OF IVL, BALLOON LOSS OF PRESSURE OCCURRED. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL CATHETER, IT WAS NOTED THAT A PORTION OF THE BALLOON REMAINED INSIDE OF THE PATIENT. A STENT WAS USED TO ENTRAP THE DETACHED PORTION OF THE BALLOON TO THE VESSEL WALL OF THE ILIAC ARTERY. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941090 ↗
• MalfunctionFeb 22, 2022Material Fragmentation; Material Rupture; Device Dislodged or Dislocated

  SHOCKWAVE BALLOON RUPTURED AND DISLODGED IN THE R(IGHT) COMMON ILIAC AFTER INFLATION. PHYSICIAN DEPLOYED STENT AND PUSHED BALLOON AGAINST WALL OF VESSEL. PHYSICIAN NOTE: WE WANT TO DO OUR FINAL SHOCKWAVE THERAPY AT THE AORTOILIAC BIFURCATION AT THE COMPLETION OF ALL THE THERAPIES DELIVERED, AND AS WE WERE DONE, THE BALLOON RUPTURED. THE MAXIMUM BALLOON DILATATION THROUGHOUT THE PROCEDURE WAS 8 ATMOSPHERES. WE THEREFORE PROCEEDED TO EXTRACT THE SHOCKWAVE BALLOON, AND UPON WITHDRAWAL WE NOTED THAT THE DISTAL HALF OF THE BALLOON REMAINED WITHIN THE BODY AT THE LEVEL OF THE RIGHT COMMON ILIAC ARTERY ON OUR WIRE. WE THEN PROCEEDED TO ADVANCE OUR SELF-EXPANDING STENT EPIC 12 X 60 THAT EXTENDED FROM THE OSTIUM OF THE RIGHT COMMON ILIAC ARTERY TO THE VERY PROXIMAL RIGHT EXTERNAL ILIAC ARTERY. THIS ENTRAPPED THE SEGMENT OF THE BALLOON THAT WAS LEFT IN THE COMMON ILIAC ARTERY. REMNANTS OF THE SHOCKWAVE BALLOON WERE TRAPPED OUTSIDE THE DEPLOYED STENT IN THE COMMON ILIAC ARTERY (BLACK DOT NOTED). THE PATIENT WAS TOLD A REMNANT OF THE SHOCKWAVE BALLOON WAS LEFT IN HIS BODY BUT SECURING AND CRUSHED OUTSIDE A STENT IN THE RIGHT COMMON ILIAC ARTERY. NO HARM TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13577102 ↗
• MalfunctionFeb 15, 2022Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A PERIPHERAL M5 INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS SUCCESSFULLY USED TO TREAT THE ILIAC ARTERY. FOLLOWING IVL, THE PHYSICIAN ATTEMPTED TO POST-DILATE THE VESSEL WITH THE IVL BALLOON BY INFLATING THE BALLOON TO 10 ATM WHICH SUBSEQUENTLY RUPTURED AT 9ATM. THE PHYSICIAN PROCEEDED TO WITHDRAW THE BALLOON AND MET RESISTANCE. UPON INSPECTION OF THE BALLOON AFTER SUCCESSFULLY REMOVING THE IVL CATHETER, IT WAS OBSERVED THAT A PORTION OF THE BALLOON WAS MISSING. MULTIPLE PICTURES IN MULTIPLE PLANES WERE TAKEN TO VERIFY THAT THE DETACHED PORTION WAS NOT LEFT INSIDE THE PATIENT. IT WAS ULTIMATELY DETERMINED THAT THE DETACHED PORTION WAS NOT LEFT INSIDE OF THE PATIENT. AS OF THE DATE OF THIS REPORT, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536537 ↗
• MalfunctionJan 6, 2022Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 PERIPHERAL LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT AN IN STENT ILIAC ARTERY. THE BALLOON WAS PULSED INSIDE OF THE STENT. UPON REMOVAL OF THE IVL CATHETER, THE PHYSICIAN ENCOUNTERED DIFFICULTY AND THE BALLOON WAS FOUND TO BE DETACHED. IT WAS DETERMINED THAT A 6F SHEATH WAS USED FOR THIS PROCEDURE WHICH IS SMALLER THAN THE INDICATED SHEATH SIZE IN THE IFU. THE DETACHED COMPONENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT USING ANOTHER SHEATH. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178866 ↗
• InjuryOct 27, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 PERIPHERAL LITHOTRIPSY (IVL) DEVICE WAS SUCCESSFULLY USED TO TREAT A LESION, USING BILATERAL KISSING BALLOON TECHNIQUE IN THE BILATERAL ILIACS; TWO (2) M5 IVL DEVICES WERE USED, ONE IN EACH ILIAC. A BALLOON RUPTURE OCCURRED WITH THE IVL BALLOON IN THE LEFT ILIAC AFTER DELIVERING 92 PULSES AT 4 ATM. UPON REMOVAL OF THE IVL CATHETER, THE PHYSICIAN NOTICED THE MARKER BAND AND PART OF THE BALLOON WAS STILL ON THE WIRE. A SURGICAL CUT DOWN INTO THE LEFT GROIN WAS PERFORMED TO FACILITATE INSERTION OF A 12 F SHEATH, AND SNARING WAS PERFORMED TO RETRIEVE THE WIRE AND DETACHED COMPONENT OF THE IVL CATHETER. THE REMAINING PORTION OF THE BALLOON WAS REMOVED SUCCESSFULLY. COVERED STENTS WERE PLACED BILATERALLY WITHOUT INCIDENT. THE PATIENT WAS AN INPATIENT AND HAD TO BE INTUBATED. POST PROCEDURE THE LEFT GROIN NEEDED TO BE SURGICALLY CLOSED. PATIENT WAS DISCHARGED ON (B)(6) 2021. THE PHYSICIAN BELIEVES THAT SHARP CALCIUM MAY HAVE CONTRIBUTED TO THE BALLOON LOSS OF PRESSURE AND SUBSEQUENT DETACHMENT OF THE IVL BALLOON CATHETER UPON WITHDRAWAL FROM THE PATIENT. IT IS NOT KNOWN WHICH IVL CATHETER RUPTURED. SO, BOTH LOT NUMBERS ARE INCLUDED IN THIS REPORT (P210226C AND P201211E).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708421 ↗