PINNACLE RSS703Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701007342), received between Oct 18, 2017 and Nov 19, 2023 — classified as 1 injury, 1 malfunction.

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

• InjuryNov 19, 2023Break; Break

  THE USER FACILITY REPORTED THAT THEY WERE PERFORMING A DECLOT ON A FISTULA WHEN THEY ATTEMPTED TO REMOVE THE INVOLVED IK DEVICE 7FR SHEATH, HALF OF IT BROKE OFF INSIDE THE FISTULA. A SNARE WAS USED TO RETRIEVE IT. THE PATIENT IS STABLE. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18166963 ↗
• MalfunctionOct 18, 2017Fracture; Leak/Splash; Fracture; Leak/Splash

  THE USER FACILITY REPORTED THAT THERE WAS CRACK/LEAK AFTER PLACEMENT OF STOPCOCK. IT WAS REPORTED THAT THE PATIENT CONDITION WAS GOOD, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/25/2017: THE CRACK WAS WHERE THE STOP COCK WOULD CONNECT AND WAS NOTICED IN THE BEGINNING OF THE PROCEDURE WHEN TRYING TO FLUSH THE SHEATH AFTER THE STOPCOCK WAS CONNECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958138 ↗