Sapphire II Pro 220-103-5UURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06934955942167), received between May 4, 2018 and May 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2018Material Rupture

  DURING AN ATHERECTOMY PROCEDURE, THE BALLOON WAS INSERTED INTO THE PROXIMAL CIRCUMFLEX STENOSIS AND INFLATED ONCE. THE BALLOON RUPTURED IN THE PROXIMAL BRANCH, RESULTING IN A RETROGRADE DISSECTION AND SLOW FLOW INTO THE LEFT CIRCUMFLEX ARTERY. A STENT WAS DEPLOYED TO RESOLVE THE DISSECTION AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7488184 ↗