PINNACLERecalls & reported problems across all models
Terumo Medical Corporation · 35 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 0
We found 35 models of PINNACLE by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 161 adverse event reports in the FDA's MAUDE database, received between May 13, 2016 and May 20, 2026 — classified as 35 injuries, 126 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (64 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PINNACLE problems
Device problems
- Leak/Splash64
- Break23
- Detachment of Device or Device Component20
- Material Deformation14
- Fracture6
- Material Split, Cut or Torn6
- Crack5
- Detachment Of Device Component5
Patient problems
- No Consequences Or Impact To Patient64
- Blood Loss41
- No Clinical Signs, Symptoms or Conditions31
- Foreign Body In Patient10
- Insufficient Information9
- No Patient Involvement9
- Hemorrhage/Blood Loss/Bleeding6
- No Code Available5
PINNACLE models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PINNACLE RSS602INTRODUCER, CATHETER33 reports
- PINNACLE RSS902INTRODUCER, CATHETER33 reports
- PINNACLE RSS901INTRODUCER, CATHETER18 reports
- PINNACLE RSS702INTRODUCER, CATHETER10 reports
- PINNACLE RSS802INTRODUCER, CATHETER7 reports
- PINNACLE RSS502INTRODUCER, CATHETER6 reports
- PINNACLE RSS601INTRODUCER, CATHETER5 reports
- PINNACLE RSB704HINTRODUCER, CATHETER4 reports
- PINNACLE RSS701INTRODUCER, CATHETER3 reports
- PINNACLE RSS603INTRODUCER, CATHETER3 reports
- PINNACLE RSB702INTRODUCER, CATHETER3 reports
- PINNACLE RSS604INTRODUCER, CATHETER3 reports
- PINNACLE RSB502INTRODUCER, CATHETER3 reports
- PINNACLE RSS402INTRODUCER, CATHETER2 reports
- PINNACLE RSS501INTRODUCER, CATHETER2 reports
- PINNACLE RSS703INTRODUCER, CATHETER2 reports
- PINNACLE RSB602INTRODUCER, CATHETER2 reports
- PINNACLE RSS804INTRODUCER, CATHETER2 reports
- PINNACLE RSS906INTRODUCER, CATHETER2 reports
- PINNACLE RSB503INTRODUCER, CATHETER2 reports
- PINNACLE RSB512INTRODUCER, CATHETER2 reports
- PINNACLE RSS801INTRODUCER, CATHETER1 report
- PINNACLE RSS101INTRODUCER, CATHETER1 report
- PINNACLE RSS403INTRODUCER, CATHETER1 report
- PINNACLE RSS905INTRODUCER, CATHETER1 report
- PINNACLE RSB601INTRODUCER, CATHETER1 report
- PINNACLE RSB603INTRODUCER, CATHETER1 report
- PINNACLE RSB703INTRODUCER, CATHETER1 report
- PINNACLE RSB803INTRODUCER, CATHETER1 report
- PINNACLE RSS606INTRODUCER, CATHETER1 report
- PINNACLE RSS706INTRODUCER, CATHETER1 report
- PINNACLE RSB705HINTRODUCER, CATHETER1 report
- PINNACLE RSB712INTRODUCER, CATHETER1 report
- PINNACLE RSB811INTRODUCER, CATHETER1 report
- PINNACLE RSB501INTRODUCER, CATHETER1 report
Recent PINNACLE adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryNov 21, 2025Separation Problem; Separation Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT WAS SCHEDULED TO HAVE AN ABLATION PROCEDURE, A 7FR TERUMO SHEATH WAS INSERTED IN RIGHT FEMORAL VEIN HOWEVER ON REMOVAL FOR A STANDARD EXCHANGE OF THE SHEATH IT FRACTURED IN THE PATIENT. THE LARGE PORTION OF SHEATH THAT WAS FRACTURED IN THE PATIENT WAS LATER REMOVED THAT DAY BY THE DOCTOR FROM VASCULAR SURGERY, THE SHEATH WAS PLACED IN A STERILE CUP. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 12NOV2025: THERE WAS TORTUOSITY EXPERIENCED WHEN THE SHEATH BREAK OCCURRED DURING REMOVAL. THE PATIENT WAS NOT IN SPASM WHEN THE BREAK OCCURRED. THERE WAS SOME RESISTANCE EXPERIENCED DURING SHEATH REMOVAL FROM THE PATIENT. THE INTENDED ABLATION PROCEDURE WAS ABLE TO BE COMPLETED FOR THE PATIENT ON (B)(6) 2025. THE PATIENT CONDITION WAS STABLE, HOWEVER TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND THEN TO THE OPERATING ROOM (OR) TO VASCULAR SURGERY FOR A CUT DOWN PROCEDURE TO RETRIEVE RETAINED PORTION OF THE SHEATH.
Patient problems: Foreign Body Embolism
MAUDE report 23619709 ↗MalfunctionNov 20, 2025Separation Problem; Separation Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE CLOSING THE ACCESS SITE THE TUBING FROM THE SHEATH DETACHED UNEXPECTEDLY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE LEFT HEART CATHETERIZATION WAS COMPLETED SUCCESSFULLY. THE SHEATH WAS IN PLACE AND THE STAFF NOTICED THAT THE TUBING RANDOMLY DISCONNECTED WITHOUT ANY APPLICATION OF FORCE NOTED. THEY WERE ABLE TO EXCHANGE FOR AN ANGIO-SEAL 6FR SHEATH AND CLOSE THE ARTERIOTOMY WITH MINIMAL BLOOD LOSS AND NO PATIENT HARM. THERE WERE NO ADDITIONAL SUPPLIES NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605640 ↗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 ↗InjuryFeb 11, 2025Difficult to Remove; Difficult to Remove
TERUMO MEDICAL RECEIVED MEDWATCH # (B)(4). THE EVENT DESCRIPTION STATES THAT: AN ELDERLY FEMALE WITH PERSISTENT ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE UNDERWENT AN ELECTROPHYSIOLOGY STUDY WITH DRUG STIMULATION AND ABLATION OF ATRIAL FIBRILLATION OF THE PULMONARY VEIN. UPON REMOVAL OF THE LEFT FEMORAL ARTERIAL SHEATH, THE DISTAL PORTION OF THE SHEATH WAS RETAINED AND COULD NOT BE ACCESSED PERCUTANEOUSLY. THE PROVIDER ELECTED TO LEAVE THE RETAINED PORTION IN PLACE. THERE WAS EVIDENCE OF GOOD HEMOSTASIS NOTED ON ULTRASOUND AS WELL AS FOLLOWING MANUAL COMPRESSION. THE SL2 SHEATH WAS REMOVED AND LEFT THE SHORT 8-FRENCH SHEATH IN PLACE ON THE RIGHT SIDE. ADDITIONALLY, WE PLACED A RIGHT FEMORAL ARTERIAL 5-FRENCH SHEATH FOR BLOOD PRESSURE MONITORING. AT THIS POINT, WE CONCLUDED THE PROCEDURE. THE PATIENT WAS EXTUBATED AND TRANSPORTED TO THE HOLDING AREA FOR FURTHER OBSERVATION AND BED REST. A SURGICAL CONSULTATION WAS OBTAINED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EMERGENT EXPLORATION OF THE LEFT COMMON FEMORAL ARTERY AND THE LEFT COMMON FEMORAL VEIN, WITH REPAIR OF THE LEFT COMMON FEMORAL ARTERY IN TWO LOCATIONS ANTERIORLY AND POSTERIORLY, AND EXPLORATION OF TH
Patient problems: Embolism/Embolus; Foreign Body In Patient
MAUDE report 21360210 ↗InjuryNov 15, 2024Break; Break
THE USER FACILITY REPORTED THAT THE 7FR SHEATH WAS USED AND A PERCLOSE WAS USED AT THE END OF THE CASE. THE SHEATH BROKE AND ONLY APPROXIMATELY 1IN OF THE SHEATH WITH THE HUB ATTACHED IS BEING RETURNED AS THAT IS WHAT CAME OUT OF THE PATIENT. THE OTHER 24CM WAS LEFT IN THE PATIENT. THEY LEFT EP AND WERE SENT UP TO THE CATH LAB TO HAVE IT REMOVED. ALL WAS SUCCESSFULLY REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20700724 ↗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 ↗InjurySep 6, 2024Material Deformation; Material Deformation
TERUMO MEDICAL OBTAINED AN FDA MEDWATCH REPORT # MW5157015. THE EVENT DESCRIPTION STATES THAT SHEATH & CATHETER BECAME KINKED DURING HEART CATHETERIZATION REQUIRING VASCULAR SURGEON INTERVENTION TO ELIMINATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20155592 ↗InjuryMay 10, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE SHEATH BROKE INSIDE OF A PATIENT. IT WAS RETRIEVED AND SAVED. ADDITIONAL INFORMATION WAS RECEIVED ON 17APR2024: THE PROCEDURE BEING PERFORMED WAS A LEFT HEART DIAGNOSTIC ANGIO VIA RIGHT FEMORAL ACCESS. WHEN ATTEMPTING TO REMOVE THE SHEATH THEY PULLED UNTIL IT SEPARATED. ALL PIECES OF SHEATH WERE REMOVED IN THE CATH LAB. THE PATIENT WAS SENT TO SURGERY FOR ENDORACTOMY PATCH AND HEMATOMA EVACUATION. SIZE OF HEMATOMA WAS NOT RECEIVED. NO HISTORY OF FEMORAL CLOSURE AT THIS HOSPITAL. GROWING SHOT TAKEN, HOWEVER, NOT AVAILABLE AT THIS TIME. REPORTED BLOOD LOSS WAS LESS THAN 250ML. THE PATIENT WAS STABLE.
Patient problems: Hematoma
MAUDE report 19288710 ↗InjuryFeb 21, 2024Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT THE INVOLVED IK DEVICE PROXIMAL PORTION OF THE SHEATH CRUMBLED UPON INSERTION. ATTEMPTED TO INSERT THE WIRE THROUGH THE SHEATH AND WAS UNABLE TO. THE SHEATH WAS CUT TO TRY AND GET WIRE ACCESS. THIS WAS NOT SUCCESSFUL, AND ACCESS TO THE VESSEL WAS LOST. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JAN 2024: PATIENT PROCEDURE WAS A NEURO DIAGNOSTIC PROCEDURE. TO RESOLVE THE ISSUE, THE SHEATH WAS PULLED, AND VESSEL ACCESS WAS LOST. PRESSURE WAS HELD AT THE SITE. NO DIFFICULT ANATOMY NOTED. THE PATIENT WAS IN STABLE CONDITION. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE INVOLVED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18755200 ↗MalfunctionJan 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
THE USER FACILITY REPORTED THAT THE 9FR SHEATH WAS USED TO PERFORM PATENT FORAMEN OVALE (PFO) CLOSURE. IT WAS USED IN THE RIGHT FEMORAL VEIN AND SUCCESSFULLY COMPLETED THE PROCEDURE. DURING REMOVAL, THE SHEATH TORE APPROXIMATELY 5CM DISTAL TO THE HUB. NO UNUSUAL RESISTANCE WAS FELT DURING REMOVAL. ADDITIONAL INFORMATION WAS RECEIVED 08JAN2024: THE PATIENT WAS STABLE AND WITH NO KNOWN COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18549020 ↗InjuryJan 20, 2024Break; Break
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW514836. THE EVENT DESCRIPTION STATES: AN 8 CM OF THE INTRODUCER SHEATH BROKE OFF INSIDE PATIENT IN PREPARATION FOR CARDIAC SURGERY. WE HAVE NEVER EXPERIENCED A PROBLEM WITH THIS PRODUCT BEFORE. DEVICE EMBEDDED IN TISSUE OR PLAQUE."
Patient problems: Foreign Body In Patient
MAUDE report 18549007 ↗MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE 7FR PINNACLE WAS INSERTED INTO THE PATIENTS RIGHT JUGULAR VEIN ON (B)(6) 2023 AND WAS THEN REMOVED IN THE CATH LAB ON (B)(6) 2023. WHEN THEY WERE REMOVING THE DRESSING OFF OF THE PATIENT/PINNACLE SHEATH THEY NOTICED THE SIDE ARM OF THE SHEATH WAS NO LONGER CONNECTED TO THE SHEATH. THERE WAS A PACEMAKER WIRE IN THE SHEATH, THIS WAS BLOCKING FLOW OUT OF THE SHEATH, PREVENTING ANY BLOOD LOSS. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509140 ↗InjuryNov 20, 2023Break; Break
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT #MW5146665. THE EVENT DESCRIPTION STATES THAT "THIRTY DAYS POST ABLATION PROCEDURE A 7 CM RETAINED SHEATH WAS REMOVED FROM PATIENT GROIN." THERE WAS A FOREIGN BODY IN THE PATIENT. THE DEVICE WAS EMBEDDED IN TISSUE OR PLAQUE.
Patient problems: Foreign Body In Patient
MAUDE report 18172629 ↗
Other Terumo Medical Corporation products
All Terumo Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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