2cm Peripheral Cutting Balloon: medical device reports that FDA received

Reports that name the brand 2cm Peripheral Cutting Balloon, received from January 2005 to September 2026

Reports that name the brand: 3,220
Reports, 12 months to September 2026: 299
Event type Malfunction: 3,07795.6% of the reports
Event type Injury: 1434.4% of the reports
Event type Death: 00% of the reports

A report is not proof that the product caused the event.

Source: U.S. Food and Drug Administration, openFDA MAUDE files, release of 23 Oct 2026Full record on Reported Reactions

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.