PINNACLE RSS402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701007229), received between Nov 22, 2017 and Nov 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2020Crack; Crack

  THE USER FACILITY REPORTED THAT IT WAS VISUALIZED PRE-TREATMENT THAT THE RADIFOCUS INTRODUCER II KIT DILATOR AND SHEATH TIP WERE CRACKED RIGHT OUT OF THE PACKAGE PRIOR TO PREPPING THE DEVICE. THE PROCEDURE WAS A SUCCESS. THE PATIENT'S CONDITION WAS STABLE. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED, IT DID NOT GO NEAR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09NOV2020. THE PROCEDURE PERFORMED WAS A LEFT HEART CATHETERIZATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10895750 ↗
• MalfunctionNov 22, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED THAT THE DILATOR SEPARATED FROM DILATOR HUB. IT WAS REPORTED THAT THE PATIENT CONDITION WAS SATISFACTORY. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052244 ↗