PINNACLE RSS603Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701007335), received between May 13, 2016 and Jun 26, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE ON THE IK SHEATH LEAKED SLOWLY AFTER THE WIRE WAS INSERTED. THE SLOW BLEED LED TO THE FORMATION OF A CLOT WITHIN THE SHEATH. A NEW SHEATH WAS REQUIRED TO COMPLETE THE CASE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 11, 2019. THE PROCEDURE THAT WAS BEING PERFORMED WAS A LEFT HEART CATHETERIZATION. A NEW RSS603 WAS USED TO COMPLETE THE CASE. BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Blood Loss

  MAUDE report 8736586 ↗
• MalfunctionMay 23, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED BLOOD LEAKING DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING A NEUROINTERVENTIONAL CASE THE STAFF NOTICED BLOOD LEAKING FROM AROUND THE HUB DISTAL TO THE CROSS CUT VALVE; THE LEAKING DID NOT OCCUR THROUGH THE VALVE ITSELF BUT AROUND THE HUB AND BEFORE THE TUBE PORTION OF THE SHEATH; BLOOD LOSS WAS ESTIMATED AT LESS THAN 10CC; THERE WAS NO DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT; THE PROCEDURE OUTCOME WAS GOOD; AND THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 5/09/2017. THE PATIENT'S CONDITION WAS REPORTED TO BE EXCELLENT.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6585248 ↗
• MalfunctionMay 13, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: EXCESSIVE LEAKING OUT OF CROSS-CUT VALVE; BLOOD LOSS WAS LESS THAN 250ML; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS REPORTED AS IN GOOD CONDITION.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 5654006 ↗