PINNACLE RSS802Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00389701007496), received between Nov 29, 2018 and May 28, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW (B)(4). THE EVENT DESCRIPTION STATES THAT "SHEATH SPLIT IN TWO AND PART OF IT NEEDED TO BE RETRIEVED AS IT WAS RETAINED IN THE PATIENT, CAUSING PROLONGED PROCEDURE/ANESTHESIA."

  Patient problems: Foreign Body In Patient

  MAUDE report 22099675 ↗
• MalfunctionNov 7, 2024Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW (B)(4). THE EVENT DESCRIPTION STATES THAT AN 8F PINNACLE SHEATH WAS DIFFICULT TO INSERT INTO THE RIGHT INTERNAL JUGULAR (R IJ) VEIN. UPON REMOVAL, THE WIRE WAS FOUND TO BE UNRAVELED, AND THE SHEATH WAS CRUMPLED AND BENT. THE EQUIPMENT WAS SAVED FOR FURTHER EXAMINATION. THE THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE ARE NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628601 ↗
• MalfunctionJul 14, 2023Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THE USER FACILITY REPORTED THAT A RIGHT LOWER EXTREMITY (RLE) ANGIOGRAM WAS PERFORMED, UPON CLOSING A REGULAR 6 FRENCH SHEATH ATTEMPTED REMOVAL RESULTED IN A SHEATH BREAKING IN HALF. THE SHEATH SEPARATED IN THE MIDDLE; THE PART ATTACHED TO HUB WAS REMOVED SAFELY. APPROXIMATELY 5CM OF SEGMENT REMAINED BEHIND IN THE PATIENT'S COMMON FEMORAL ARTERY. PHYSICIAN ACCESSED AN 8 FRENCH PINNACLE SHEATH ON THE CONTRALATERAL SIDE TO SNARE OUT HOWEVER IT WAS UNSUCCESSFUL. PATIENT WAS THEN TRANSFERRED TO A CATH LAB WHERE AN ADDITIONAL PERCUTANEOUS PROCEDURE WAS PERFORMED AND RESULTED IN A SUCCESSFUL REMOVAL. PATIENT WAS IN STABLE CONDITION. THE EVENT OCCURRED POST-TREATMENT. THERE IS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 16 JUN 2023: TWO SEPARATE SHEATHS WERE USED ON SAME PROCEDURE. ADDITIONAL INFORMATION RECEIVED 22 JUN 2023: REMOVAL OF SHEATH WAS DONE IN A SURGICAL SETTING AT A DIFFERENT LOCATION. THE INTERVENTION INVOLVED IN THE PERCUTANEOUS PROCEDURE FOR REMOVAL WAS AN 8 FRENCH SHEATH ACCESSED THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND A 035 GLIDEWIRE ADVANCED UP INTO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330416 ↗
• MalfunctionMay 21, 2020Crack; Crack

  THE USER FACILITY REPORTED THAT WHEN THE IK DEVICE WAS IN THE FEMORAL ARTERY THAT THE HUB HAD CRACKED. THE HUB WAS CRACKED ON BOTH SIDES. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED.ADDITIONAL INFORMATION WAS RECEIVED 30APR2020. THE PROCEDURE BEING PERFORMED WAS AN ANGIOGRAPHY PROCEDURE. THE SHEATH WAS USED TO COMPLETE THE CASE SUCCESSFULLY.ADDITIONAL INFORMATION WAS RECEIVED 01MAY2020. THE SHEATH WAS A FEMORAL VENOUS SHEATH. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079914 ↗
• InjuryNov 22, 2019Break; Break

  A MAUDE DATABASE SEARCH CONDUCTED ON (B)(6) 2019 FOUND MAUDE REPORT NUMBER (B)(4). THE EVENT DESCRIPTION STATES: "THE PATIENT WAS HAVING A HEART CATH AND THE TERUMO SHEATH BROKE IN HALF DURING THE CASE. THE PATIENT HAD TO BE TAKEN TO SURGERY TO RETRIEVE THE BROKEN PART."

  Patient problems: Blood Loss

  MAUDE report 9364852 ↗
• InjuryApr 16, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE IK DEVICE SHEATH BROKE. TERUMO MEDICAL RECEIVED AN FDA MEDWATCH WITH ADDITIONAL INFORMATION ON APRIL 5, 2019. THE EVENT DESCRIPTION STATES: SUCCESSFUL ABLATION ACCESSORY PATHWAY OF LEFT LATERAL PARTICIPATING IN ORT. AT THE TIME OF EXCHANGE OF 6 FR SHEATH FOR 8 FR SHEATH TO PLACE (INTRACARDIAC ECHOCARDIOGRAM) ICE INTO THE RIGHT ATRIUM, THE SHEATH TORE IN HALF. IT IS STILL UNCLEAR HOW THIS HAPPENED, AS THE MANIPULATION OF THE SHEATH WAS NOT OUT OF THE ORDINARY, IT WAS STILL LOCATED ON THE GUIDE WIRE. A LASSO SNARE WAS ADVANCED FROM ONE OF THE OTHER FEMORAL SHEATHS OVER THE IJ WIRE, AND ON TO THE PROXIMAL PORTION OF THE TORN SHEATH, CONTROLLING IT. THE RIGHT IJ (INTERNAL JUGULAR) WAS THEN ACCESSED WITH ULTRASOUND AND THE SNARE WAS PLACED OVER THE SHEATH. BOTH WERE SECURED. THE WIRE WAS THEN REMOVED THROUGH THE IJ ACCESS SITE. ADDITIONAL CONSOLIDATION ABLATION WAS PERFORMED AND THE PATIENT WAS MONITORED FOR 30 MINUTES WITHOUT RECURRENCE OF AP. PATIENT WAS RELEASED POST PROCEDURE, WHICH WAS CONSIDERED OUTPATIENT. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: No Information

  MAUDE report 8520245 ↗
• MalfunctionNov 29, 2018Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT UPON INSERTION OF THE IK SHEATH, IT ROLLED UP ON ITSELF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116022 ↗