2cm Peripheral Cutting Balloon® M001PCB60201350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729813729), received between Jan 15, 2021 and Apr 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Material Rupture

  IT WAS REPORTED A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 100% STENOSIS, WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY, INVOLVING IN-STENT RESTENOSIS WITHIN PREVIOUSLY PLACED STENTS IN THE P1 AND P2 SEGMENTS OF THE POPLITEAL ARTERY, WITH ADDITIONAL DISTAL DISEASE. THE AFFECTED SEGMENT WAS PRE-DILATED USING A 5.0 X 120 MM STERLING BALLOON INFLATED TO NOMINAL PRESSURE. IT WAS NOTED THAT THE STENT IN THE P2 SEGMENT WAS UNDERSIZED, RESULTING IN A FLOW-LIMITING NARROWING. A 5.0 MM X 20 MM X 135 CM OTW PERIPHERAL CUTTING BALLOON WAS ADVANCED OVER A V18 GUIDEWIRE TO TREAT THE LESION. DURING INFLATION AT 10 ATMOSPHERES FOR APPROXIMATELY 10 SECONDS WITHIN THE P2 SEGMENT, BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED WITHOUT COMPLICATION. A SECOND 6.0 MM X 20 MM OTW PERIPHERAL CUTTING BALLOON WAS SUBSEQUENTLY ADVANCED TO THE SAME SEGMENT AND INFLATED TO 10 ATMOSPHERES; BALLOON RUPTURE AGAIN OCCURRED DURING INFLATION. THE DEVICE WAS REMOVED WITHOUT RESISTANCE. FOLLOWING THESE EVENTS, A 5.0 X 40 MM X 135 CM CHARGER BALLOON WAS ADVANCED AND INFLATED TO 20 ATMOSPHERES. THEREAFTER, A 5.0 X 150 MM X 150 CM RANGER DEVICE WAS USED TO TREAT THE DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896890 ↗
• MalfunctionApr 2, 2026Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE SHEATH AND DAMAGED THE SHEATH. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ARTERIOVENOUS GRAFT STENOSIS. AN 8.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS USED. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. PRIOR TO REMOVAL, THE BALLOON WAS FULLY DEFLATED, HOWEVER, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE SHEATH AND SLICING IT OPEN. A SURGICAL CUTDOWN WAS DONE TO REMOVE THE DEVICE FROM THE PATIENT. ANOTHER 6.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES. PRIOR TO REMOVAL, THE BALLOON WAS FULLY DEFLATED, HOWEVER, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE SHEATH AND SLICING IT OPEN. THE BALLOON AND THE SHEATH WERE REMOVED SAFELY. A NEW SHEATH WAS INSERTED SO CLOSURE COULD BE SECURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767752 ↗
• MalfunctionFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS FISTULA IN THE UPPER EXTREMITY. A 6.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON CATHETER WAS ADVANCED ACROSS THE NARROW ARTERIAL ANASTOMOSIS. DURING SEVERAL DILATION, THE BALLOON WOULD NOT INFLATE ABOVE 5 ATMOSPHERES AND WOULD NOT HOLD THAT PRESSURE. IT WAS DETERMINED THAT THE BALLOON MUST HAVE BURST. THE BALLOON WAS PULLED OUT OF THE SHEATH AND USED A PLAIN OLD BALLOON ANGIOPLASTY TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON BURST WAS CONFIRMED, AS THE CONTRAST WAS NOTED TO BE COMING OUT OF THE BALLOON. THE BALLOON WAS INFLATED TWICE UP TO 4 ATMOSPHERES WHEN IT RUPTURED. THE BLADES WERE UNABLE TO FOLD COMPLETELY DURING REMOVAL, CAUSING THE SHEATH TO BE SLICED ON THE WAY OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393828 ↗
• MalfunctionSep 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLADE CAME LOOSE. A 6.00MMX2.0CMX135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BLADE CAME LOOSE WHEN THEY WERE PULLING IT OUT OF THE SHEATH AT THE END OF THE CASE. NO COMPLICATIONS REPORTED AND NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15475374 ↗
• MalfunctionJun 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.00MM/ 2.0CM/ 135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED WHEN INFLATED. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957535 ↗
• MalfunctionJan 15, 2021Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND FIBROUS NON CALCIFIED FEMORAL VEIN GRAFT. A 6.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE BALLOON WAS INFLATED AT 1ATM EVERY 5 SECONDS. BALLOON WAS CONTINUALLY INFLATED EVEN THOUGH THE PRESSURE WOULD DECREASE QUICKLY SO BLOOD RETURN WAS NOT NOTICED AS SOON AS IT PROBABLY COULD HAVE BEEN. THE BALLOON WAS UP FOR AT LEAST 60 SECONDS. THE PHYSICIAN TRIED TO KEEP THE BALLOON AT NOMINAL PRESSURE; HOWEVER, IT QUICKLY BURST BEFORE REACHING NOMINAL PRESSURE OF 6ATM AND THE BLOOD RETURN KEPT GETTING PUSHED BACK DUE TO ROTATION OF THE INFLATION DEVICE. THE DOCTOR WAS DISPLEASED THAT SHE COULD NOT BRING THE BALLOON TO 10ATM WHICH IS THE RATED BURST AS THIS WAS A TOUGH LESION. THE BALLOON WAS PINNED PULLED OFF THE WIRE FROM THE PATIENT'S BODY WITH NO PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, NOTHING BROKE OFF AND WAS LEFT IN THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11178825 ↗