PINNACLE RSS702Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00389701007489), received between Nov 22, 2016 and May 20, 2026 — classified as 2 injuries, 8 malfunctions.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4) THE EVENT DESCRIPTION STATES: "THE CORDIS HAD A CRACK JUST ABOVE WHERE THE MEDICATION WAS CONNECTED. THIS LED TO MEDICATION LEAKAGE, DUE TO THE LOW VOLUME OF THE MEDICATION (1.8ML/HR) THIS LED TO THE PATIENT MOST LIKELY NOT RECEIVING THE MEDICATION. DURING EVALUATION OF WHERE THE LEAK WAS COMING FROM IT WAS NOTED THAT THE LINE WAS FULL OF AIR. HIGH RISK MEDICATION, TREPROSTINIL WAS RUNNING THROUGH THIS LINE. STOPPING THIS MEDICATION ABRUPTLY COULD HAVE SEVERE ADVERSE EFFECTS. THE PATIENT WAS ALSO AT HIGH RISK OF AN AIR EMBOLISM DUE TO THE LINE FILLING WITH AIR QUICKLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236322 ↗
• MalfunctionMar 18, 2026

  AT HOSPITAL, PATIENT CAME FOR OUTPATIENT FISTULAGRAM ON LOWER LEFT ARM. AT THE END OF THE CASE, ACCESS SHEATH 7F WAS REMOVED FROM PATIENT. AFTER REMOVAL, IT WAS NOTED THAT ONLY A PARTIAL PIECE WAS REMOVED. AFTER ASSESSING, PATIENT BROUGHT TO OR TO OPEN FISTULA AND REMOVE RETAINED PIECE OF SHEATH. REMOVED BROKEN PIECE OF SHEATH RETAINED BY BIOMED. IT WAS NOTED BY STAFF THAT PATIENT HAD METAL STENT IN UPPER LEFT ARM. PHYSICIAN NOTED THAT IT DID NOT IMPACT SHEATH REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24625719 ↗
• 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 10079901 ↗
• MalfunctionNov 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE USER FACILITY REPORTED THAT TWO IK SHEATHS WERE PULLED AFTER THE ACT CAME DOWN AND IT WAS DISCOVERED THAT BOTH SHEATHS HAD BEEN CUT LONGITUDINALLY ALONG THE LENGTH OF THE SHEATH CANNULA. THE PROCEDURE WAS A BILATERAL COMMON ILIAC REVASCULARIZATION. BILATERAL 7 FR COMMON FEMORAL ARTERIAL ACCESS WAS GAINED. THE PHYSICIAN BALLOONED THE RIGHT THEN THE LEFT COMMON ILIAC USING ONE SINGLE BOSTON SCIENTIFIC 7MMX2CM PERIPHERAL CUTTING BALLOON. 7MMX60MM AND 7MMX80MM IN PACT ADMIRAL DRUG ELATING BALLOONS WERE THEN USED TO TREAT THE LEFT AND RIGHT LESIONS, RESPECTIVELY. ARTERIOGRAPHY AT THE END OF CASE DEMONSTRATED THAT THERE WAS NO TRAUMA DISSECTION/PERFORATION TO THE PATIENT'S VASCULATURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Blood Loss

  MAUDE report 9318399 ↗
• MalfunctionNov 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE USER FACILITY REPORTED THAT TWO IK SHEATHS WERE PULLED AFTER THE ACT CAME DOWN AND IT WAS DISCOVERED THAT BOTH SHEATHS HAD BEEN CUT LONGITUDINALLY ALONG THE LENGTH OF THE SHEATH CANNULA. THE PROCEDURE WAS A BILATERAL COMMON ILIAC REVASCULARIZATION. BILATERAL 7 FR COMMON FEMORAL ARTERIAL ACCESS WAS GAINED. THE PHYSICIAN BALLOONED THE RIGHT THEN THE LEFT COMMON ILIAC USING ONE SINGLE BOSTON SCIENTIFIC 7MMX2CM PERIPHERAL CUTTING BALLOON. 7MMX60MM AND 7MMX80MM IN PACT ADMIRAL DRUG ELATING BALLOONS WERE THEN USED TO TREAT THE LEFT AND RIGHT LESIONS, RESPECTIVELY. ARTERIOGRAPHY AT THE END OF CASE DEMONSTRATED THAT THERE WAS NO TRAUMA DISSECTION/PERFORATION TO THE PATIENT'S VASCULATURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Blood Loss

  MAUDE report 9318394 ↗
• MalfunctionSep 25, 2019Material Frayed; Material Frayed

  THE USER FACILITY REPORTED THAT DURING A RIGHT HEART CATHETERIZATION, THE TIP OF THE IK SHEATH WAS NOTED TO BE FRAYED OUT OF THE PACKAGING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9118642 ↗
• InjuryJun 26, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE ON THE IK DEVICE LEAKED DURING THE CASE, SWITCHED FOR ENGAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 11, 2019. TWO DEVICES FAILED FOLLOWED BY THE USE OF A COMPETITORS DEVICE. THE PROCEDURE BEING PERFORMED WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). BLOOD LOSS WAS LESS THEN 250CC.

  Patient problems: Blood Loss

  MAUDE report 8736585 ↗
• MalfunctionNov 22, 2016Kinked; Kinked

  THE USER FACILITY REPORTED A KINK IN THE SHEATH. FOLLOW UP COMMUNICATIONS WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE SHEATH KINKED OUT OF THE PACKAGE; AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 6122533 ↗
• MalfunctionNov 22, 2016Kinked; Kinked

  THE USER FACILITY REPORTED A KINK IN THE SHEATH. FOLLOW UP COMMUNICATIONS WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE SHEATH KINKED OUT OF THE PACKAGE. THERE WAS NOT PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 6122526 ↗
• MalfunctionNov 22, 2016Kinked; Kinked

  THE USER FACILITY REPORTED A KINK IN THE SHEATH. FOLLOW UP COMMUNICATIONS WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE SHEATH KINKED OUT OF THE PACKAGE. THERE WAS NOT PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 6122515 ↗