2cm Peripheral Cutting Balloon® M001PCB6020900Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729813743), received between Jan 24, 2019 and Dec 1, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 16, 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.

• MalfunctionDec 1, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS ADVANCED OVER THE WIRE INTO THE FISTULA. DURING FIRST INFLATION, THE BALLOON DID NOT INFLATE AND POPPED FOR UNKNOWN REASON. THE DEVICE WAS REMOVED INTACT WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815491 ↗
• InjuryOct 4, 2021Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON CUT THE SHEATH. THE TARGET LESION WAS LOCATED IN THE LEFT BRACHIAL ACCESS. A 6.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON (PCB) WAS SELECTED FOR USE. DURING REMOVAL OF THE PCB, RESISTANCE WAS FELT UPON ENTERING THE SHEATH. THE DEVICE WAS REMOVED AND CONTINUED TO TREAT THE LESION WITH A DRUG COATED BALLOON. HOWEVER, SOME BLEEDING WAS NOTICED AT THE SHEATH SITE AND AFTER EXAMINING THE SHEATH IT WAS NOTICED THAT IT HAD BEEN COMPROMISED BY A HORIZONTAL CUT. NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED VIA MEDWATCH # (B)(4) THAT THE PERCENTAGE OF STENOSIS WAS 50%, AND LESION HAD FOCAL SEVERITY OF CALCIFICATION AND VERY LITTLE OF TORTUOUSITY. ALSO, THE BALLOON WAS SLOWLY REMOVED AFTER PROPER DEFLATION. THE BLEEDING WAS NOTED ONLY AFTER THE REMOVAL OF THE SHEATH. IN ADDITION, A CUTTING BALLOON WAS USED TO OPEN THE ARTERY THAT SUPPLIES THE ARM ENDOVASCULARLY. DURING REMOVAL, THE BLADES OF THE DEVICE LACERATED THE ARTERY OF THE PATIENT AT THE ENTRY SITE AS WELL AS THE SHEATH WHICH WAS REMOVED. THE BLADES ARE SUPPOSED TO BE RETRACTED TO PREVENT ANY DAMAGE WHEN THE BALLOON WAS DEFLATED. HOWEVER, THE BLADE

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569133 ↗
• MalfunctionApr 15, 2021Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON SHAF GOT INFLATED. THE TARGET LESION WAS LOCATED IN THE BRACHIALCEPHALIC VEIN. A 6.00MM/ 2.0CM/ 90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE BALLOON DID NOT INFLATE INSTEAD IT FILLED IN THE SPACE BEFORE THE BALLOON AND CREATED A BUBBLE IN THE CATHETER SHAFT. THE DEVICE WAS REMOVED OVER THE WIRE AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672203 ↗
• MalfunctionSep 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A STENT GRAFT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.00MM/2.0CM/90CM OTW PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982410 ↗
• MalfunctionJan 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED INTO THE PATIENT AND WAS INFLATED THREE TIMES SUCCESSFULLY. HOWEVER, THE BALLOON COULD NOT BE INFLATED COMPLETELY DURING FOURTH INFLATION AND RUPTURED. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND WAS STILL INTACT; NO PARTS OF THE BALLOON WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8275280 ↗