Small Peripheral Cutting Balloon® M001PCBO4015140F0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729819769), received between Nov 1, 2017 and Mar 30, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2020Break; Break

  IT WAS REPORTED THAT THE BALLOON FELL APART. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THE BALLOON FELL APART UPON OPENING. 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 9897818 ↗
• MalfunctionApr 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE IN THE LOWER EXTREMITY POPLITEAL ARTERY. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT FIRST INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519107 ↗
• MalfunctionJan 23, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA VEIN GRAFT ANGIOPLASTY APPROACH. A STENOSED TARGET LESION WAS LOCATED AT BASILLIC VEIN. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INFLATION, THE PHYSICIAN STATED THAT THE BALLOON DID NOT INFLATE. IT WAS NOTED THAT A BALLOON RUPTURE OCCURRED THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE UPON COMPLETION OF THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271333 ↗
• MalfunctionNov 1, 2017Detachment Of Device Component

  WE OPENED AN ANGIOPLASTY CUTTING BALLOON. THIS TYPE OF BALLOON AND LITTLE BLADES AROUND IT SO IT COMES PACKAGED WITH A SAFETY SHEATH COVERING THE BALLOON. BEFORE PLACING THE BALLOON ON A WIRE TO ENTER THE PATIENT, THE SHEATH IS REMOVED. WHEN THE ENDOVASCULAR TECH REMOVED THE SHEATH, THE ENTIRE BALLOON BLADES AND ALL REMAINED IN THE SHEATH AND CAME COMPLETELY OFF THE CATHETER. DEVICE DID NOT REACH PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6993242 ↗