Diamondback Coronary SIP-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005138), received between Jun 10, 2019 and Jun 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 16, 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.

• MalfunctionJun 10, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  DURING TREATMENT OF A LESION WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), BLOOD WAS OBSERVED FLOWING BACK INTO THE DEVICE. THE BLOOD WAS UNABLE TO BE FLUSHED FROM THE DEVICE USING THE SALINE PUMP. A SECOND PUMP WAS USED AND FUNCTIONED WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL OAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684206 ↗