PINNACLE RSB704HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00389701008295), received between Aug 11, 2022 and Jun 29, 2023 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THE INVOLVED IK DEVICE SHEATH BEGAN TO LEAK BLOOD FROM THE SHEATH AT THE CONNECTION BETWEEN THE ORANGE HUB AND THE WHITE SHEATH. PROCEDURE WAS COMPLETED WITH THIS SHEATH. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. PATIENT WAS IN STABLE CONDITION. THERE WAS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234794 ↗
• MalfunctionMay 11, 2023Crack; Crack

  THE USER FACILITY REPORTED THAT THERE WAS A CRACK NOTICED AT THE HUB OF THE SHEATH DURING THE PROCEDURE ONCE THE BALLOON WAS REMOVED AFTER INFLATION. A CONQUEST 40 BALLOON SIZE 12MM X 40MM WAS USED. THE PROCEDURE BEING PERFORMED WAS A RIGHT HARM FISTULA ANGIOPLASTY. THE PATIENT WAS STABLE AND THE STABLE. PROCEDURE SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE CRACK IS IN THE WHITE PART OF THE SHEATH AT THE BASE OF THE HUB. THE PROCEDURE WAS COMPLETED WITH THE SAME SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915518 ↗
• InjuryMay 3, 2023Break; Break

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE THE CONQUEST BALLOON WAS PASSED THROUGH THE INVOLVED IK SHEATH AND INFLATED IN THE SUBCLAVIAN VEIN. AT FIRST THE BALLOON APPEARED TO POP AND WAS REPORTED TO BE REMOVED WITHOUT DIFFICULTY. A SECOND CONQUEST BALLOON WAS THEN ADVANCED, DURING THE INFLATION OF THE BALLOON IT WAS DISCOVERED THAT THE SHEATH WAS ON THE WIRE DISTAL TO THE BALLOON. THE BALLOON WAS REMOVED AND THE WIRE WITH THE SHEATH ON IT WAS LEFT IN THE PATIENT AND SECURED TO THE ACCESS SITE. AN AMBULANCE WAS CALLED, AND THE PATIENT WAS TRANSFERRED TO A HOSPITAL WHERE THE FOREIGN BODY RETRIEVAL PROCEDURE WAS PERFORMED. THE REMOVAL OF THE SHEATH WAS SUCCESSFUL. THE ORIGINAL PROCEDURE WAS A RIGHT ARM FISTULAGRAM WITH INTERVENTION AND ANGIOPLASTY OF THE SUBCLAVIAN VEIN. THE CORRECTIVE PROCEDURE WAS A FOREIGN BODY RETRIEVAL VIA THE LEFT FEMORAL VEIN. PATIENT CONDITION WAS STABLE AND PLANNED TO BE DISCHARGED HOME. THE PROCEDURE OUTCOME WAS SUCCESSFUL FOREIGN BODY RETRIEVAL. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT REQUIRED MEDICAL OR SURGICAL. ADDITIONAL INFORMATION WAS RECEIVED ON 05 APRIL 2023: THE SHEATH PIECE THAT REQUIRED TO BE SURGICAL REMOVED FROM THE PATIENT WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 16865684 ↗
• InjuryAug 11, 2022Fracture; Fracture

  THE USER FACILITY REPORTED THAT DURING A FISULAGRAM PROCEDURE, A 7FR X 4CM PINNACLE SHEATH WAS USED WITH A 14MM X 40MM ATLAS PTA BALLOON. THIS BALLOON WAS INFLATED, REMOVED AND AN ANGIOGRAM WAS TAKEN. THE SAME BALLOON WAS THEN REINSERTED AND USED AGAIN. UPON REMOVING THE ATLAS PTA BALLOON, THE PHYSICIAN NOTICED THAT THE SHEATH CAME APART AT THE HUB. THE DISTAL END OF THE SHEATH WAS STILL ON THE WIRE INSIDE THE PATIENT'S ARTERY. A SNARE WAS USED TO REMOVE THE LOOSE PIECE OF THE SHEATH. THE PATIENT (PT) WAS ABLE TO RECOVER AND LEFT THE DEPARTMENT WITH NO ISSUES. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A SUCCESS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 18 JUL 2022: THERE WAS NO ADDITIONAL TESTING OTHER THAN THE ANGIOGRAM PERFORMED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210238 ↗