2cm Peripheral Cutting Balloon® M001PCB50201350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729813699), received between Feb 17, 2020 and Apr 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 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 24896881 ↗
• MalfunctionMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON HAD A HOLE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. A 5.00 MM/2.0 CM/135 CM PERIPHERAL CUTTING BALLOON CATHETER WAS PREPARED AND ADVANCED INTO THE PATIENT FOR ANGIOPLASTY. HOWEVER, UPON INFLATION, THE BALLOON DID NOT HOLD PRESSURE. THE DEVICE WAS REMOVED AND EXAMINED ON THE BACK TABLE, WHERE A HOLE WAS FOUND IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689999 ↗
• MalfunctionSep 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 7 ATMOSPHERES UPON SECOND INFLATION. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749034 ↗
• MalfunctionJan 7, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A BALLOON PUNCTURE OCCURRED. A 5.00MM/2.0CM/135 PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. IT WAS NOTED THAT THE BALLOON WAS PUNCTURED PRIOR TO OPENING THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196546 ↗
• MalfunctionAug 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT A NOMINAL PRESSURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420165 ↗
• MalfunctionFeb 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A 5.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST WHEN INFLATED AT 4ATM INSIDE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716440 ↗