PINNACLE RSS901Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00389701007281), received between Dec 6, 2016 and Jul 14, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Component Missing; Component Missing

  THE USER FACILITY REPORTED THAT THE 9FR INTRODUCER KIT (IK) DEVICE WAS MISSING THE PIECE THAT KEEPS THE BLOOD FROM COMING OUT. THE PROCEDURE WAS AN ANGIOGRAM. ANOTHER DEVICE WAS OPENED TO CONTINUE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THE SCRUB TECH STATED THAT THE DEVICE LOOKED DIFFERENT HOWEVER, THOUGHT IT WAS A NEW MODEL. THE MISSING COMPONENT WAS CONFIRMED THE BE THE VALVE AT THE BASE OF THE HUB. THEY STATED IT DID NOT BECOME DISLODGED DURING USE, IT WAS ALREADY MISSING WHEN OPENED. DURING THE PROCEDURE THE BLOOD LEAKAGE WAS MINIMAL AND WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED AS INTENDED WITH THE SECOND DEVICE USED. THE ISSUE WAS DISCOVERED BEFORE ADVANCING THE WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168279 ↗
• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DILATOR WOULD NOT FIT INTO THE SHEATH AFTER IT WAS TAKEN OUT OF THE PACKAGING WHILE PREPPING FOR THE CASE. THE SHEATH AND DILATOR WERE NEVER USED. THE PATIENT WAS IN GOOD CONDITION AND THE PROCEDURE OUTCOME WAS NOT AFFECTED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 04JAN2021. THE PROCEDURE WAS A HEART CATHETERIZATION. A NEW TERUMO SHEATH WAS PULLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407445 ↗
• MalfunctionMar 6, 2020Break; Leak/Splash; Break; Leak/Splash

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "INTRODUCER SHEATH ARTERIAL DILATORS - BLOOD POURED OUT OF HEMOSTASIS VALVE - EXPLANTED AND REPLACED. TAVR PROCEDURE SUCCESSFULLY PERFORMED. PATIENT TO ICU IN STABLE CONDITION. 9 FR SHEATH PLACED IN PATIENT'S BODY. ONCE THE DILATOR FOR THE SHEATH WAS REMOVED, WE REALIZED THE DIAPHRAGM FOR THE SHEATH WAS BROKEN AND ARTERIAL BLOOD WAS SQUIRTING OUT THE SHEATH. WE REPLACED THE WHOLE SHEATH WITH ANOTHER 9 FR SHEATH, AND IT STARTED LEAKING AS WELL, BUT NOT QUITE AS BAD. THE DEVICE FAILED. THE DEVICE DID NOT DO WHAT IS WAS SUPPOSED TO DO." ADDITIONAL INFORMATION WAS RECEIVED ON 20FEBRUARY2020: THE SECOND DEVICE (TERUMO PINNACLE INTRODUCER SHEATH FR.) WAS UTILIZED - REPLACING THE FIRST DEVICE (EXPLANTED). THE SECOND WAS HOW THEY COMPLETED THE PROCEDURE. THE ESTIMATED BLOOD LOSS WAS ESTIMATED TO BE 50CC'S. THE PATIENT WAS BROUGHT TO THE HYBRID OPERATING ROOM AND AFTER SUITABLE CONSCIOUS SEDATION WAS OBTAINED THE PATIENT WAS PREPPED AND DRAPED IN A STERILE MANNER. A RIGHT FEMORAL ARTERIAL SHEATH WAS PLACED. THE LEFT FEMORAL ARTERIAL AND VENOUS SHEATH WERE PLACED. THE PACEMAKER LEAD WAS ADVANCED I

  Patient problems: Blood Loss

  MAUDE report 9802195 ↗
• MalfunctionFeb 4, 2020Break; Fluid/Blood Leak

  INTRODUCER SHEATH ARTERIAL DILATORS - BLOOD POURED OUT OF HEMOSTASIS VALVE - EXPLANTED AND REPLACED. TAVR PROCEDURE SUCCESSFULLY PERFORMED. PATIENT TO ICU IN STABLE CONDITION. 9 FR SHEATH PLACED IN PATIENT'S BODY. ONCE THE DILATOR FOR THE SHEATH WAS REMOVED, WE REALIZED THE DIAPHRAGM FOR THE SHEATH WAS BROKEN AND ARTERIAL BLOOD WAS SQUIRTING OUT THE SHEATH. WE REPLACED THE WHOLE SHEATH WITH ANOTHER 9 FR SHEATH, AND IT STARTED LEAKING AS WELL, BUT NOT QUITE AS BAD.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9665290 ↗
• MalfunctionJan 23, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER II KIT SHEATH WAS INSERTED IN THE NORMAL FASHION AND WHEN THE DILATOR WAS REMOVED, BLOOD UNCONTROLLABLY FLOWED OUT THROUGH THE VALVE. THE BLOOD LOSS WAS GREATER THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. A 9FR TERUMO SHEATH WAS USED DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) REVISION. ONCE THE SHEATH WAS INSERTED INTO THE PATIENT AND THE INNER STYLET WAS REMOVED, BLOOD UNCONTROLLABLY FLOWED OUT FROM THE SHEATH DO TO A FAULTY VALVE. THE BLOOD CONTINUED TO FLOW OUT UNTIL THE PHYSICIAN WAS ABLE TO CHANGE OUT THE SHEATH; OVER A WIRE, FOR A NEW ONE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE CASE WAS COMPLETED IN THE NORMAL FASHION AS IT NORMALLY WOULD BE COMPLETED WITH THE EXCEPTION OF SWITCHING OUT THE 9FR SHEATH. THE BLOOD LOSS WAS AN ESTIMATED 500CC, AND THERE WAS NO TREATMENT DONE FOR BLOOD LOSS BESIDES OBSERVATION.

  Patient problems: Blood Loss

  MAUDE report 8271249 ↗
• MalfunctionMay 10, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE PHYSICIAN NOTICED THE SHEATH WAS LEAKING FROM THE HUB DURING A PROCEDURE WHEN A 9FR INTER CARDIAC ECHO PROBE WAS INSERTED INTO THE SHEATH. THE EVENT HAD NO EFFECT ON THE PATIENT. ANOTHER 9FR DEVICE WAS USED AND THE CASE COMPLETED NORMALLY. IT WAS REPORTED THAT THERE WAS NOT A LOT OF BLOOD LOSS.

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

  MAUDE report 7502012 ↗
• MalfunctionMay 10, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE PHYSICIAN NOTICED THE SHEATH WAS LEAKING FROM THE HUB DURING A PROCEDURE WHEN A 9FR INTER CARDIAC ECHO PROBE WAS INSERTED INTO THE SHEATH. THE EVENT HAD NO EFFECT ON THE PATIENT. ANOTHER 9FR DEVICE WAS USED AND THE CASE COMPLETED NORMALLY. IT WAS REPORTED THAT THERE WAS A LOT OF BLOOD LOSS.

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

  MAUDE report 7502009 ↗
• MalfunctionNov 29, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHILE FLUSHING THE SHEATH ON THE TABLE PRIOR TO THE PROCEDURE, THE TUBING APPEARED TO HAVE A LEAK. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTED BLOOD LOSS. IT WAS REPORTED THAT THE PATIENT IS FINE. THE REPORTED SHEATH HAS NO EFFECT ON THE PROCEDURE OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068340 ↗
• MalfunctionSep 19, 2017Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE SHEATH VALVE COMPLETELY DETACHED FROM HUB DURING PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 8/24/2017: IT WAS REPORTED THAT THE BLOOD LOSS WAS 5CC. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS WITH THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFUL AND THAT THE PATIENT WAS STAYING OVERNIGHT. THE ONLY OTHER DEVICE USED WITH THE REPORTED PRODUCT WAS THE WIRE THAT CAME WITH THE SHEATH.

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

  MAUDE report 6875926 ↗
• MalfunctionAug 31, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT UPON USAGE THE DOCTOR FOUND THAT THE BLEED BACK VALVE DID NOT WORK. IT WAS REPORTED THAT THE BLOOD LOSS WAS 100 CC. IT WAS REPORTED THAT THE PATIENT HAD NO INJURIES AND WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

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

  MAUDE report 6833861 ↗
• MalfunctionJul 27, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED THAT REPORTED THE SHEATH HAD NO VALVE IN IT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PATIENT IS FINE. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

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

  MAUDE report 6746903 ↗
• MalfunctionJan 27, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE WAS NOT PRESENT INSIDE THE SHEATH DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE SCRUB PERSON COULD NOT ADVANCE THE DILATOR INTO THE SHEATH OF A 9FR. PINNACLE SHEATH ASSEMBLY DURING AN ABLATION PROCEDURE; UPON EVALUATION FROM THE SCRUB PERSON THE SHEATH VALVE WAS NOT PRESENT INSIDE THE SHEATH; THE A-FIB ABLATION WAS COMPLETED SUCCESSFULLY; BLOOD LOSS WAS LESS THAN 250 CC; AND THE PATIENT WAS REPORTED IN STABLE CONDITION.

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

  MAUDE report 6282913 ↗
• MalfunctionJan 27, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AN ELECTROPHYSIOLOGY ATRIAL FIBRILLATION ABLATION PROCEDURE WAS BEING CONDUCTED USING AN INTRA-CARDIAC ECHOGRAPHY CATHETER VIA THE LEFT FEMORAL VEIN ACCESS FOR ICE (INTRA CARDIAC ECHO) DURING A-FIB ABLATION; A 9FR. PINNACLE WAS PREPPED IN NORMAL FASHION; UPON INSERTION OF THE SHEATH INTO THE RIGHT FEMORAL VEIN AND REMOVAL OF THE SHEATH DILATOR, THE SHEATH VALVE MALFUNCTIONED AND RESULTED IN A CONTINUOUS FLOW OF BLOOD FROM THE SHEATH; THE SHEATH WAS REMOVED AND REPLACED WITH A DIFFERENT 9FR. PINNACLE WITH NO ISSUES; IT WAS REPORTED THAT THE MALFUNCTION OF THE VALVE RESULTED IN MINIMAL BLOOD LOSS, A SPECIFIC AMOUNT WAS NOT PROVIDED; THE A-FIB ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS CONFIRMED TO BE IN STABLE CONDITION.

  Patient problems: Blood Loss

  MAUDE report 6282883 ↗
• MalfunctionDec 15, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE MD ATTEMPTED TO FLUSH THE SHEATH AND NOTICED SALINE COMING OUT THE VALVE AND THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6176636 ↗
• MalfunctionDec 6, 2016Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION PROVIDED ON 12/7/2016 CONFIRMED THE FOLLOWING; THE LEAKAGE WAS FOUND PRE-TREATMENT AND THE DEVICE WAS NOT USED ON THE PATIENT; AND THE SHEATH WAS REPLACED WITH ANOTHER SHEATH.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6149092 ↗
• MalfunctionDec 6, 2016Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION PROVIDED ON 12/7/2016 CONFIRMED THE FOLLOWING; THE LEAKAGE WAS FOUND PRE-TREATMENT AND THE DEVICE WAS NOT USED ON THE PATIENT; AND THE SHEATH WAS REPLACED WITH ANOTHER SHEATH.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6149090 ↗
• MalfunctionDec 6, 2016Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2016 CONFIRMED THE FOLLOWING; BLOOD LOSS WAS LESS THAN 250 ML; AND THE SHEATH WAS REPLACED WITH ANOTHER SHEATH.

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

  MAUDE report 6149077 ↗
• MalfunctionDec 6, 2016Split; Split

  ADDITIONAL INFORMATION PROVIDED ON 12/7/2016 CONFIRMED THE FOLLOWING: THE USER FACILITY REPORTED THAT THIS WAS A CLEAN SHEATH BREAK; APPROXIMATELY 1/4 OF SHEATH TIP BROKE OFF; THE TIP WAS SURGICALLY REMOVED BY AN INTERVENTIONAL RADIOLOGIST; AND THE PATIENT'S CONDITION WAS STABLE. THE PATIENT CALLED ON 12/2/2016 AND STATED THE FOLLOWING: THE PROCEDURE WAS DONE IN (B)(6); THE TIP OF THE PINNACLE BROKE OFF AND TRAVELED TO THE PULMONARY ARTERY; IT HAD TO BE SURGICALLY REMOVED; AND THE PATIENT CALLED CUSTOMER CARE AND REPORTED HAVING DIFFICULTY BREATHING. THE INFORMATION PROVIDED BY THE PATIENT WAS CONFIRMED TO BE RELATED TO THIS REPORT ON 12/7/2016.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6149072 ↗