2cm Peripheral Cutting Balloon® M001PCB7020900Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729813774), received between Apr 5, 2019 and Oct 3, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2022Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A METALLIC PIECE PROTRUDED UPON REMOVAL. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED GRAFT TO AXILLARY VEIN ANASTOMOSIS. A 7.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. UPON REMOVAL OF THE BALLOON, BALLOON WAS FULLY DEFLATED AND WHEN REMOVED OVER THE WIRE FROM THE SHEATH A METALLIC PIECE WAS PROTRUDING FROM IT, LIKELY ONE OF THE CUTTING COMPONENTS OF THE BALLOON. A COMPLETION FISTULA GRAM WAS PERFORMED THOUGH THE SHEATH SHOWING GOOD FLOW THROUGH THE GRAFT. THE DEVICE WAS DEFLATED ANGIOGRAPHICALLY AND THE SHEATH WAS REMOVED OVER THE V18 WIRE INTACT; HOWEVER THERE WAS AN APPROXIMATELY 1 INCH CUT LENGTHWISE IN THE SHEATH THAT APPEARED TO HAVE BEEN MADE FROM A SHARP CUT AND WAS CONFIRMED CAUSED BY THE BALLOON AS IT WAS NOT PRESENT PRIOR TO THE USED OF THE BALLOON. AS PER PHYSICIAN'S OPINION, THE BLADE LIFTED WAS POSSIBLY CAUSED FROM THE INFLATION AT THE LESION. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527863 ↗
• MalfunctionAug 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 7.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AT INFLATION PROCESS, IT WAS NOTED THAT THE BALLOON RUPTURED AT 4ATM. THE DEVICE WAS REMOVED OVER THE WIRE WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332064 ↗
• InjuryMay 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BALLOON DETACHMENT OCCURRED. A 7.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON DETACHED UPON PERFORMING A DIALYSIS ACCESS ANGIOPLASTY. THE PROCEDURE WAS CHANGED TO AN OPEN "CUT-DOWN" FOR BALLOON ISOLATION AND SURGICALLY REMOVED IT FROM THE VESSEL. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10087993 ↗
• InjurySep 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST AND LACERATED THE VEIN. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RADIAL CEPHALIC FISTULA. A 7.00 MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST AT 8ATM UPON THIRD INFLATION. THE BALLOON NEEDS TO BE TAKEN OUT FROM THE PATIENT'S BODY BUT IT WAS NOT FULLY COLLAPSED. SUBSEQUENTLY, THE BALLOON LACERATED THE CEPHALIC VEIN AND THE NON-BSC SHEATH. THE PATIENT WAS THEN SUTURED AND THE PROCEDURE WAS COPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 9084704 ↗
• InjuryApr 5, 2019Break; Break

  IT WAS REPORTED THAT THE BLADE WAS BROKEN. A 7.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE BLADE WAS BROKEN AND WAS THEN RETRIEVED FROM THE PAITENT'S BODY WITH NO HARM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487325 ↗