PINNACLE RSS902Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00389701007502), received between Apr 21, 2017 and Jun 1, 2023 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (24 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THEY HAD DIFFICULTY INSERTING THE INVOLVED 9 FRENCH PINNACLE DILATOR. IT WAS VERY TIGHT AND NOTED RESISTANCE. ONCE THE DILATOR WAS INSERTED AND COMPLETELY ADVANCED INTO THE LEFT FEMORAL VEIN, EXCESSIVE AMOUNTS OF BLEEDING WAS NOTED AT THE CROSSCUT VALVE SITE. THEY EXCHANGED THE SHEATH FOR A NEW 9 FRENCH SHEATH AND THE SAME EXACT SCENARIO OCCURRED. DIFFICULTY ADVANCING DILATOR INTO THE SHEATH AND EXCESSIVE BLEEDING CONTINUED. FINISHED THE CASE QUICKLY WITH FINGER/GAUZE OVER SHEATH SITE AS MUCH AS POSSIBLE DESPITE BLEEDING. UPON EXAMINATION POST PROCEDURE THE CROSSCUT VALVE LEAFLETS APPEARED TO BE MISSING, SHEATH APPEARS THICK AND BOWED. PROCEDURE OUTCOME WAS SUCCESSFUL. ESTIMATED BLOOD LOSS WAS LESS 250CC. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED HOME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE PROCEDURE BEING PERFORMED WAS A RIGHT LEG VENOGRAM AND STENT PLACEMENT. BLEEDING WAS CONSISTENT BUT THEY WERE ABLE TO PLACE A FINGER/GAUZE OVER THE HUB, NO MAJOR CHANGE IN H&H (LAB VALUE), THEY MOVED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17039379 ↗
• MalfunctionAug 16, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER II KIT WAS USED DURING AN EP STUDY PROCEDURE. THE 9FR SHEATH WAS PUT IN AND WHEN THE DILATOR WAS PULLED OUT IT BEGAN LEAKING FROM THE VALVE, ANOTHER OF THE SAME LOT WAS PULLED AND IT ALSO IMMEDIATELY STARTED LEAKING. A THIRD SAME DEVICE OF A DIFFERENT LOT WAS USED AND WAS FINE. NO DEVICES WERE USED IN THE SHEATHS. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325131 ↗
• MalfunctionAug 16, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER II KIT WAS USED DURING AN EP STUDY PROCEDURE. THE 9FR SHEATH WAS PUT IN AND WHEN THE DILATOR WAS PULLED OUT IT BEGAN LEAKING FROM THE VALVE, ANOTHER OF THE SAME LOT WAS PULLED AND IT ALSO IMMEDIATELY STARTED LEAKING. A THIRD SAME DEVICE OF A DIFFERENT LOT WAS USED AND WAS FINE. NO DEVICES WERE USED IN THE SHEATHS. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325127 ↗
• MalfunctionMar 3, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER II KIT SHEATH WAS USED FOR FEMORAL ACCESS AT THE BEGINNING OF THE PROCEDURE FOR A PHYSICIAN MODIFIED AORTIC GRAFT. THE SHEATH LEAKED BLOOD PROFUSELY ONCE THE DILATOR WAS REMOVED. THE DILATOR WAS REINSERTED AND THE ANOTHER 9FR SHEATH WAS USED FROM A DIFFERENT LOT NUMBER WITH NO ISSUES. THE PROCEDURE OUTCOME WAS NOT AFFECTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 12FEB2021. THE BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403589 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR, AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10829472 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR AND THAT IT WAS LEAKY. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10829471 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10829470 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10829465 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10829192 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR, AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10829191 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR, AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10829187 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10828480 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10828458 ↗
• MalfunctionNov 12, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED TERUMO SHEATH PINNACLE 9F 10CM DEVICE ONE-WAY VALVE PUSHED INTO THE SHEATH WHEN INTRODUCING THE DILATOR, AND THAT IT WAS LEAKY.

  Patient problems: Insufficient Information

  MAUDE report 10828433 ↗
• MalfunctionOct 5, 2020Material Deformation; Material Deformation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # 1000870000-2020-8062. THE EVENT DESCRIPTION STATES: "DURING AN EP STUDY WITH AMBULATION THE SHEATH WAS INTRODUCED TO THE RIGHT FEMORAL VEIN. WHEN THE WIRE AND DILATOR WERE PULLED BACK, THE SHEATH VALVE CAME OFF. THE PATIENT WAS BLEEDING BACK FROM THE SHEATH, AND THE DOCTOR REPLACED THE SHEATH WITH A NEW FR 10CM TERUMO SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE DATE OF THE EVENT IS AUGUST 2020." ADDITIONAL INFORMATION WAS RECEIVED ON 14SEPTEMBER2020: THE BLOOD LOSS WAS LESS THAN 250CC'S.THREE SHEATHS WERE INSERTED INTO THE RFV (9,8,7FR) USING ULTRASOUND GUIDANCE. AN 8FR INTRACARDIAC ECHOCARDIOGRAPHY CATHETER WAS INSERTED AND ADVANCED INTO THE RIGHT ATRIUM. INTRACARDIAC ECHOCARDIOGRAPHY WAS PERFORMED, AND WAS LATER USED TO GUIDE THE TRANSSEPTAL PUNCTURE. A DECAPOLAR DIAGNOSTIC CATHETER WAS ADVANCED TO THE CORONARY SINUS FOR LEFT ATRIAL PACING AND RECORDING. CATHETERS/WIRES WERE ADVANCED TO THE HEART UNDER FLUOROSCOPIC GUIDANCE. THE RIGHT FEMORAL VENOUS 8FR SHEATH WAS EXCHANGED OVER A WIRE FOR A MEDIUM CURL AGILIS. ADDITIONAL INFORMATION WAS RECEIVED PER MEDWATCH ON 18SEPTEMBER2020: "PATIENT PROBLEMS: HEMORR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10627748 ↗
• MalfunctionSep 1, 2020Detachment of Device or Device Component

  INCIDENT DESCRIPTION: SHEATH INTRODUCED TO RIGHT FEMORAL VEIN (RFV). WHEN WIRE AND DILATOR WERE PULLED BACK, THE SHEATH VALVE CAME OFF. PATIENT WAS BLEEDING BACK FROM SHEATH, AND THE DOCTOR REPLACED THE SHEATH WITH A NEW 9FR 10CM TERUMO SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10476209 ↗
• MalfunctionJul 24, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE IK DEVICE VALVE APPEARED TO BE LEAKING, IN ADDITION THERE WERE AIR BUBBLES NOTICED INSIDE THE PORT WHEN A SYRINGE WAS USED TO PULL BLOOD BACK FOR A ACT PURPOSES. THIS 9 FRENCH SHEATH WAS USED FOR A ELECTROPHYSIOLOGY (EP) PROCEDURES, IN ADDITION THREE ADDITIONAL SHEATHS OF VARIOUS SIZES SUCH AS A 8FR WERE USED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE WAS SATISFACTORY. THE BLOOD LOSS WAS LESS THAN 250CC'S. AN I.C.E. EP CATHETER WAS PLACED IN THE 9 FRENCH SHEATH. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 10319602 ↗
• MalfunctionJul 24, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE IK DEVICE VALVE APPEARED TO BE LEAKING, IN ADDITION THERE WERE AIR BUBBLES NOTICED INSIDE THE PORT WHEN A SYRINGE WAS USED TO PULL BLOOD BACK FOR A ACT PURPOSES. THIS 9 FRENCH SHEATH WAS USED FOR A ELECTROPHYSIOLOGY (EP) PROCEDURES, IN ADDITION THREE ADDITIONAL SHEATHS OF VARIOUS SIZES SUCH AS A 8FR WERE USED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE WAS SATISFACTORY. THE BLOOD LOSS WAS LESS THAN 250CC'S. AN I.C.E. EP CATHETER WAS PLACED IN THE 9 FRENCH SHEATH. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 10319600 ↗
• MalfunctionJul 24, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE IK DEVICE VALVE APPEARED TO BE LEAKING, IN ADDITION THERE WERE AIR BUBBLES NOTICED INSIDE THE PORT WHEN A SYRINGE WAS USED TO PULL BLOOD BACK FOR A ACT PURPOSES. THIS 9 FRENCH SHEATH WAS USED FOR A ELECTROPHYSIOLOGY (EP) PROCEDURES, IN ADDITION THREE ADDITIONAL SHEATHS OF VARIOUS SIZES SUCH AS A 8FR WERE USED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE WAS SATISFACTORY. THE BLOOD LOSS WAS LESS THAN 250CC'S. AN I.C.E. EP CATHETER WAS PLACED IN THE 9 FRENCH SHEATH. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 10319598 ↗
• MalfunctionJun 22, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE ON THE IK SHEATH WAS LEAKING. ADDITIONAL INFORMATION WAS RECEIVED ON 28MAY2020. THE PROCEDURE PERFORMED WAS AN AFIB ABLATION USING AN 8FR ICE CATHETER. THE PROCEDURE WAS A SUCCESS USING THE DEVICE. THE PATIENT CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181325 ↗
• InjuryDec 12, 2019Break; Break

  THE USER FACILITY REPORTED THAT AN IK SHEATH WAS PULLED FROM THE GROIN IN A VENOUS EP CASE. WHEN THE PHYSICIAN PULLED THE SHEATH OUT, IT BROKE APPROXIMATELY 3 CM BELOW THE HUB, LEAVING APPROXIMATELY 7 CM OF SHEATH IN THE PATIENT'S GROIN. THE PATIENT HAD NO PRIOR GROIN ACCESS. VASCULAR SURGEON WAS CALLED IN TO REMOVE THE REMAINING SHEATH LEFT IN THE GROIN VIA CUT DOWN. THE SHEATH WAS SUCCESSFULLY REMOVED. THE PATIENT EXPERIENCED NO BLOOD LOSS. THE PHYSICIAN WAS ABLE TO CONTINUE WITH THE PROCEDURE AFTER THE VASCULAR SURGEON REMOVED THE REMAINING SHEATH AND COMPLETED THE CASE. THE PATIENT WAS REPORTED TO BE STABLE AND THE PROCEDURE WAS SUCCESSFUL. THERE WERE NO OTHER EQUIPMENT OR DEVICES USED WITH THE REPORTED PRODUCT.

  Patient problems: No Code Available

  MAUDE report 9460820 ↗
• MalfunctionNov 21, 2019Component Missing; Component Missing

  THE USER FACILITY REPORTED AN UNKNOWN ISSUE WITH THE IK DEVICE DURING A PROCEDURE. UPON INVESTIGATION OF THE RETURN SAMPLE ON 14OCT2019, IT WAS NOTED THAT THE VALVE WAS MISSING FROM THE SHEATH HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356957 ↗
• MalfunctionNov 21, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THEY INSERTED A IK DEVICE SHEATH AND DILATOR. AS THEY REMOVED THE DILATOR FROM THE SHEATH, THEY LOOKED DOWN AND THE ENTIRE ROUND RUBBER VALVE CAME OUT WITH THE DILATOR. THEY APPLIED PRESSURE AND INSERTED ANOTHER SHEATH. PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED 29OCTOBER2019: ELECTROPHYSIOLOGY PROCEDURE WAS PERFORMED. WHILE THE DILATOR WAS BEING REMOVED, THE CLEAR RUBBER VALVE CAME OUT WITH THE DILATOR. THE DOCTOR DID NOT LOSE WIRE ACCESS. THEY USED ANOTHER A IK DEVICE AND SUCCESSFULLY FINISHED THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353645 ↗
• MalfunctionOct 3, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING AN AFIB CASE WHERE THEY ARE USING AN 8FR ULTRASOUND ICE CATHETER. THEY NOTICED AN ISSUE WHEN THEY HOOK UP THE EXTENSION SIDE ARM FOR ACT. THE SHEATH LEAKED WHEN THEY DREW BACK, THEY NOTICED AIR IN THE SIDE PORT LINE. IT WAS REPORTED THAT THEY SAW POSSIBLE TEARS IN THE HEMOSTATIC VALVE. THE PATIENT WAS IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. THE BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: Blood Loss

  MAUDE report 9150451 ↗
• MalfunctionOct 3, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING AN AFIB CASE WHERE THEY ARE USING AN 8FR ULTRASOUND ICE CATHETER. THEY NOTICED AN ISSUE WHEN THEY HOOK UP THE EXTENSION SIDE ARM FOR ACT. THE SHEATH LEAKED WHEN THEY DREW BACK, THEY NOTICED AIR IN THE SIDE PORT LINE. IT WAS REPORTED THAT THEY SAW POSSIBLE TEARS IN THE HEMOSTATIC VALVE. THE PATIENT WAS IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. THE BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: Blood Loss

  MAUDE report 9150448 ↗