Peripheral RotaLink® Plus M0011402250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729838944), received between Jul 8, 2019 and Jul 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 8, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE SHEATH. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 2.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, THE BURR BECAME STUCK ON A 7F SHEATH. THE DEVICE WAS PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768011 ↗