PINNACLE RSB512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701009384), received between May 19, 2016 and Sep 27, 2018 — classified as 2 malfunctions.

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

• MalfunctionSep 27, 2018Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THE IK SHEATH WAS KINKED OUT OF THE PACKAGE. THE PRODUCT NEVER TOUCHED THE PATIENT. THE PROCEDURE COMPLETED SUCCESSFULLY WITH A SECOND SHEATH. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED, THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 17, 2018. THE PROCEDURE BEING PERFORMED WAS A PERIPHERAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7913866 ↗
• MalfunctionMay 19, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE SHEATH LEAKED FROM THE VALVE PERSISTENTLY DURING THE PROCEDURE FROM THE TIME THE CATHETER WAS INSERTED UNTIL THE SHEATH WAS REMOVED FROM THE BODY. BLOOD LOSS WAS LESS THAN 250ML. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS IN STABLE CONDITION.

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

  MAUDE report 5667616 ↗