PINNACLE PRECISION ACCESS SYSTEMRecalls & reported problems across all models
Terumo Medical Corporation · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 11 models of PINNACLE PRECISION ACCESS SYSTEM by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Sep 21, 2026 — classified as 36 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (30 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 PRECISION ACCESS SYSTEM problems
Device problems
- Break30
- Material Separation14
- Physical Resistance/Sticking8
- Failure to Advance6
- Unraveled Material6
- Leak/Splash4
- Difficult to Advance3
- Material Fragmentation3
Patient problems
- No Consequences Or Impact To Patient29
- Foreign Body In Patient19
- No Clinical Signs, Symptoms or Conditions12
- Device Embedded In Tissue or Plaque10
- Blood Loss6
- No Patient Involvement3
- No Known Impact Or Consequence To Patient2
- Claudication1
PINNACLE PRECISION ACCESS SYSTEM models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PINNACLE PRECISION ACCESS SYSTEM 70-6160INTRODUCER, CATHETER24 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-5160INTRODUCER, CATHETER16 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-5165INTRODUCER, CATHETER11 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-4160INTRODUCER, CATHETER9 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-5130INTRODUCER, CATHETER6 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-7160INTRODUCER, CATHETER6 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-6130INTRODUCER, CATHETER4 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-8160INTRODUCER, CATHETER3 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-4165INTRODUCER, CATHETER2 reports
- PINNACLE PRECISION ACCESS SYSTEM 70-7130INTRODUCER, CATHETER1 report
- PINNACLE PRECISION ACCESS SYSTEM 70-8130INTRODUCER, CATHETER1 report
Recent PINNACLE PRECISION ACCESS SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Unraveled Material
Terumo received the following reported information: During a Peripheral Intervention, the wire nitinol unraveled when pulling back through the needle. Once out the physician decided to use a regular 4 French Micropuncture sheath. The patient was stable, and no wire was left in patient. The blood loss was less than 250cc.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841250 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780966 ↗InjuryMar 30, 2026Break; Unraveled Material
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT INTERVENTIONAL CARDIOLOGIST WAS PERFORMING AN UNKNOWN TYPE OF PROCEDURE. THE WIRE INCLUDED IN THE 6FR PRECISION ACCESS KIT UNRAVELED AND BROKE OFF IN THE PATIENT. VASCULAR SURGEON WAS NOTIFIED AND IT WAS DETERMINED WIRE FRAGMENT WAS NOT IN VESSEL AND WAS TOO RISKY TO INTERVENE. THE APPROXIMATE SIZE OF THE WIRE THAT BROKE OFF INSIDE THE PATIENT IS UNKNOWN. THE WIRE BROKE OFF AT THE ACCESS SITE. THE PATIENT REMAINED IN STABLE CONDITION. THEY STATED THAT THE WIRE FELT DIFFERENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE TAKING PLACE FOR THE PATIENT AT THE TIME OF THE EVENT WAS A DIAGNOSTIC HEART CATHETERIZATION.
Patient problems: Foreign Body In Patient
MAUDE report 24723977 ↗InjuryMar 12, 2026Peeled/Delaminated
TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION: AN ISSUE OCCURRED WITH THE 5 FRENCH PRECISION TERUMO PRODUCT. NO BLOOD LOSS WAS REPORTED. TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED: "THE TIP OF WIRE FOR THE PRECISION SHEATH SHEARED OFF THE REMAINDER OF THE WIRE AS THE WIRE WAS PASSED THROUGH THE NEEDLE. THE MAJORITY OF THE TIP WAS WITHIN THE FEMORAL ARTERY AND THERE WAS A SHORT PORTION THAT REMAINED EXTERNAL TO THE PATIENT AFTER THE NEEDLE WAS REMOVED. THE TIP WAS CAREFULLY REMOVED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ENDOVASCULAR AORTIC ANEURYSM REPAIR".
Patient problems: Foreign Body In Patient
MAUDE report 24582367 ↗InjuryOct 31, 2025Material Separation; Material Separation
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5176002. THE MEDWATCH EVENT DESCRIPTION STATED THAT: "WHILE INSERTING RIGHT INTERNAL JUGULAR CATHETER, SHEATH BROKE REQUIRING RETRIEVAL."
Patient problems: Foreign Body In Patient
MAUDE report 23439665 ↗MalfunctionJun 4, 2025Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE DOCTOR PLACED THE PRECISION SHEATH AND WHEN REMOVED WIRE, THE WIRE WAS SHREDDED. THERE WAS NO HARM TO PATIENT AND PROCEDURE WAS COMPLETED WITH NO ISSUES. PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC CHOLECYSTECTOMY (L/C). THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 09MAY2025: NOTHING WAS LEFT IN THE PATIENT PER THE PHYSICIAN. THE PHYSICIAN USED A DIFFERENT MICRO WIRE AND EXCHANGED THE PRECISION FOR A PINNACLE WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22144480 ↗MalfunctionNov 2, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT DURING SET UP WHILE FLUSHING AND ADVANCING DILATOR INTO SHEATH, THE DILATOR TIP BROKE. THE PROCEDURE WAS AN ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024: ANOTHER SIMILAR KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DILATOR PRIOR TO FLUSHING AND ADVANCING INTO SHEATH. NO IMPACT TO PATIENT AS THIS OCCURRED DURING THE SET UP PRIOR TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20594820 ↗InjuryAug 24, 2024Break; Break
THE USER FACILITY REPORTED AN ISSUE WITH A PINNACLE PRECISION NIT KIT DURING A VENOGRAM FOR THROMBECTOMY. THE ISSUE WAS WIRE BREAKING DURING ACCESS; THE DISTAL TIP DETACHED AND WAS IN THE ARTERY. THE DOCTOR MANAGED TO LOCATE AND RETRIEVED THE WIRE TIP. THE PATIENT REMAINED STABLE; THE PROCEDURE WAS COMPLETED WITHOUT FURTHER MEDICAL INTERVENTIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JUL 2024: THE PHYSICIAN SNARED THE WIRE TIP. IT IS UNKNOWN IF THERE WAS CALCIUM OR STENOSIS PRESENT. THE DOCTOR SAID THAT THE ILIAC BIFURCATION WAS VERY CALCIFIED.
Patient problems: Foreign Body In Patient
MAUDE report 20058140 ↗MalfunctionMay 23, 2024Unraveled Material; Unraveled Material
THE USER FACILITY REPORTED THAT THE INVOLVED NEEDLE AND WIRE WERE INSERTED, THE NEEDLE WAS THEN REMOVED. DURING THE ATTEMPT TO INSERT THE WIRE AND DILATOR, THE WIRE BECAME STUCK AND UNRAVELED. THE EVENT OCCURRED INTRA-OPERATIVE. THE TYPE OF PROCEDURE PERFORMED WAS A PERIPHERAL. NO BLOOD LOSS WAS REPORTED. THERE IS NO DIRECT CLAIM THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 03 MAY 2024: THE WIRE UNRAVELED AS THE DILATOR AND WIRE WERE BEING REMOVED. HOWEVER, WE SUCCESSFULLY REMOVED BOTH THE WIRE AND DILATOR WITHOUT COMPLICATIONS. A DIFFERENT 5FR TERUMO SHEATH WAS SUBSEQUENTLY UTILIZED. THE PROCEDURE WAS COMPLETED WITH SUCCESS, LEAVING NO WIRE INSIDE THE PATIENT. THE PATIENT REMAINED STABLE THROUGHOUT, WITH NO CONCOMITANT MEDICAL DEVICES USED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19389079 ↗InjuryMay 10, 2024Break; Break
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES THAT THE SHEATH FRACTURED WHILE INSIDE THE FEMORAL ARTERY. THE ATTENDING PHYSICIAN MANAGED TO SNARE THE SHEATH, THOUGH THE CAUSE OF THE BREAKAGE WAS UNCLEAR. DIAGNOSIS: SUCCESSFUL DEPLOYMENT OF THE PLANNED PFO CLOSURE DEVICE. THE PROCEDURE WAS COMPLICATED BY A SEVERED 6 FRENCH SHEATH THAT HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY, WHICH WAS EVENTUALLY RETRIEVED USING A 7 FRENCH SNARE. THE PROCEDURE WAS INITIALLY INTENDED AS A PLANNED PATENT FORAMEN OVALE (PFO) CLOSURE DUE TO ACUTE CEREBROVASCULAR ACCIDENT (CVA) WITH A LIKELY PARADOXICAL EMBOLISM.
Patient problems: Embolism/Embolus; Obstruction/Occlusion
MAUDE report 19294416 ↗InjuryMay 9, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE INVOLVED IK DEVICE SHEATH BROKE IN HALF DURING EXCHANGE. HALF OF THE SHEATH GOT STUCK IN THE PATIENT'S INFERIOR VENA CAVA (IVC), REQUIRING IR FOREIGN BODY REMOVAL. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 17 APR 2024: THE TYPE OF PROCEDURE BEING PERFORMED WAS AN ATRIAL FIBRILLATION ABLATION. THE USER DID ENCOUNTER RESISTANCE DURING REMOVAL. ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. PATIENT IS IN STABLE CONDITION. THE WIRE WAS EXCHANGED TO A BIOSENSE WEBSTER VIZIGO SHEATH.
Patient problems: Foreign Body In Patient
MAUDE report 19274953 ↗InjuryApr 30, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE TIP OF THE INVOLVED GUIDE WIRE (THAT COMES WITH THE INTRODUCER) EMBEDDED/RETAINED IN THE PATIENT AND THE END WAS STRETCHED OUT. THIS WAS DISCOVERED WHEN THE WIRE WAS REMOVED. THE TIP WAS CONFIRMED BY FLUOROSCOPY TO BE RETAINED IN THE PATIENT. NO BLOOD LOSS WAS REPORTED. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION. THERE WAS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.
Patient problems: Foreign Body In Patient
MAUDE report 19213359 ↗InjurySep 22, 2023Break; Break
THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS PERFORMING A PATENT FORAMEN OVALE (PFO) CLOSURE PROCEDURE AND ACCESSED THE PATIENT'S COMMON FEMORAL VEIN WITH TWO SHEATHS: ONE 6FR PRECISION SHEATH AND ONE 8FR PRECISION SHEATH. EARLY IN THE PROCEDURE, THE DOCTOR REPORTEDLY PULLED BACK ON THE 8FR PRECISION SHEATH, AND IT BROKE OFF MID-SHAFT. THE CUSTOMER REPORTED THAT HE USED A SNARE TO REMOVE THE BROKEN PIECE. THE PROCEDURE WAS SUCCESSFUL WITH NO REPORTED IMPACT TO THE PATIENT. FOLLOWING THE PROCEDURE, THE PATIENT REMAINED STABLE. PROCEDURE WAS SUCCESSFUL. THERE WAS NO IMPACT OR HARM TO THE PATIENT. NO OTHER MEDICAL PRODUCTS OR THERAPY WAS USED PRIOR TO THE SHEATH BREAKING, ACCORDING TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17803473 ↗MalfunctionAug 18, 2023Fracture; Fracture
THE USER FACILITY REPORTED THAT THE PRECISION DILATOR BROKE WHEN INSERTING INTO THE SHEATH. A NEW ONE WAS OPENED, AND THE PROCEDURE WAS COMPLETED BY USING THE NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17570998 ↗InjuryJul 14, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 01 AUG 2023: THE PROCEDURE WAS A LEFT HEART CATHETERIZATION, SO ONLY WIRES AND CATHETERS WERE PASSED THROUGH THE SHEATH. THE PATIENT DID HAVE SOME SCARRING AROUND THE ACCESS SITE FROM PREVIOUS PROCEDURES. THERE WAS MINIMAL RESISTANCE, HOWEVER NOTHING THAT SHOULD HAVE CAUSED THE SHEATH TO SEPARATE THE WAY IT DID. THE BODY OF THE SHEATH SEEMED VERY THIN AND WEAK COMPARED TO OTHER SHEATHS WE HAVE USED PREVIOUSLY.
Patient problems: Foreign Body In Patient
MAUDE report 17330414 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page