PINNACLE RSS701Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701007267), received between Jun 13, 2019 and Jan 12, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE 7FR PINNACLE WAS INSERTED INTO THE PATIENTS RIGHT JUGULAR VEIN ON (B)(6) 2023 AND WAS THEN REMOVED IN THE CATH LAB ON (B)(6) 2023. WHEN THEY WERE REMOVING THE DRESSING OFF OF THE PATIENT/PINNACLE SHEATH THEY NOTICED THE SIDE ARM OF THE SHEATH WAS NO LONGER CONNECTED TO THE SHEATH. THERE WAS A PACEMAKER WIRE IN THE SHEATH, THIS WAS BLOCKING FLOW OUT OF THE SHEATH, PREVENTING ANY BLOOD LOSS. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509140 ↗
• InjuryNov 20, 2023Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT #MW5146665. THE EVENT DESCRIPTION STATES THAT "THIRTY DAYS POST ABLATION PROCEDURE A 7 CM RETAINED SHEATH WAS REMOVED FROM PATIENT GROIN." THERE WAS A FOREIGN BODY IN THE PATIENT. THE DEVICE WAS EMBEDDED IN TISSUE OR PLAQUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18172629 ↗
• MalfunctionJun 13, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE ON THE IK DEVICE LEAKED AFTER INSERTION OF THE J WIRE. THE BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 21, 2019. THE PROCEDURE BEING PERFORMED WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT. THE ENGAGED SHEATH WAS REMOVED AND REPLACED WITH A NEW SHEATH.

  Patient problems: Blood Loss

  MAUDE report 8695123 ↗