PINNACLE PRECISION ACCESS SYSTEM 70-5165Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00389701010885), received between Mar 26, 2018 and Nov 2, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT DURING ASSEMBLY OF THE INVOLVED IK PRECISION SHEATH, THE TIP OF THE DILATOR FRACTURED. IT WAS NEVER INSIDE THE PATIENT. A SECOND SHEATH WAS OPENED AND USED FOR THE PROCEDURE. PROCEDURE WAS LOWER EXTREMITY ANGIOGRAM. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959976 ↗
• InjuryApr 14, 2023Entrapment of Device; Material Fragmentation; Entrapment of Device; Material Fragmentation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5115543. THE EVENT DESCRIPTION STATES: PATIENT WAS ADMITTED FOR OUTPATIENT INTERVENTIONAL RADIOLOGY (IR) FOR STAGED PROCEDURES. AT THE COMPLETION OF THE ARTERIOGRAM, EMBOLIZATION PRIOR TO CRYOABLATION, A SMALL METALLIC FOREIGN BODY WAS SEEN PERSISTING IN THE REGION OF INTERVENTION ON REVIEW OF IMAGING FILMS. AFTER CESSATION OF THE PROCEDURE, SEPARATE RADIOGRAPHS OF THE PELVIS AND RIGHT HIP WERE OBTAINED, AS WELL AS A FOCUSED ULTRASOUND, DEMONSTRATING AN APPARENT RETAINED SECTION OF WIRE WITHIN THE SUBCUTANEOUS TISSUES. SUPERFICIAL TO THE RIGHT FEMORAL ARTERY AND VEIN, NORMAL FLOW WAS ESTABLISHED AT THE RIGHT COMMON FEMORAL ARTERY AND VEIN. RETRIEVAL WAS FELT TO BE MORE TRAUMATIC THAN THE POTENTIAL FOR COMPLICATIONS, THEREFORE NO RETRIEVAL ATTEMPT WAS MADE AT THE TIME. SUBSEQUENT ATTEMPT TO REMOVE THE FOREIGN BODY LATER WAS UNSUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 21 MAR 2023: THE BROKEN WIRE WAS CONFIRMED TO STILL BE WITHIN THE PATIENT. THE DATE OF THE ATTEMPT TO REMOVE THE WIRE WAS (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 22 MAR 2023: THERE WAS NO HARM TO THE PATIENT'S OR

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body Embolism

  MAUDE report 16741340 ↗
• InjuryMar 8, 2023Break; Break

  THE USER FACILITY REPORTED THAT A SHEATH WAS USED ON A PACEMAKER CASE. THE TIP OF THE SHEATH BROKE OFF INTO PATIENT AND WAS NOT ABLE TO BE RETRIEVED. THIS WAS CONFIRMED BY X-RAY. THE PATIENT WAS STABLE AND OKAY. PROCEDURE OUTCOME WAS UNKNOWN, AND IT WAS UNKNOWN IF THEY WERE ABLE TO FINISH THE CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 10 FEB 2023: THE TIP WAS ATTEMPTED TO BE REMOVED BY A WIRE AND A SNARE THROUGH THE LEFT ARM. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO ENHANCE VISUALIZATION. THE TIP WAS LOCATED BY X-RAY IN THE LEFT SUBCLAVIAN VEIN. THE CAUSE OF THE TIP BREAKING IS UNDETERMINED. THE PROCEDURE WAS COMPETED. THE ACCOUNT HAD NO OTHER ISSUES WHILE IMPLANTING THE PACEMAKER. THE ESTIMATED BLOOD LOSS WAS 50CC.

  Patient problems: Foreign Body In Patient

  MAUDE report 16510193 ↗
• MalfunctionDec 11, 2020Break; Break

  THE USER FACILITY REPORTED THE IK PRECISION DEVICE DILATOR BROKE OFF WHILE THE SHEATH WAS BEING INSERTED INTO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 01DECEMBER2020: THE TYPE OF PROCEDURE WAS ATHERECTOMY OF THE LEG. THE DEVICE DID NOT BREAK IN THE PATIENT. IT BROKE ON THE BACK TABLE WHILE THE DILATOR WAS INSERTED INTO THE SHEATH. THE ATHERECTOMY WAS COMPLETED. A REGULAR TERUMO SHEATH WAS USED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992662 ↗
• MalfunctionMay 24, 2019Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT WHEN THE PHYSICIAN WAS TRYING TO ADVANCE THE IK SHEATH FOR A LEFT HEART CATHETERIZATION (LHC) PROCEDURE VIA RIGHT GROIN ACCESS; HE TOOK THE INTRODUCER OUT AND LEFT THE WIRE, PUT THE INTRODUCER BACK IN TO ADVANCE THE SHEATH AND THEN WHEN HE TOOK THE INTRODUCER OUT AGAIN, THE WIRE BROKE OFF. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 8, 2019. THERE WAS NO HARM TO THE PATIENT; THEY WERE ABLE TO REMOVE THE BROKEN WIRE SEGMENT. THEY CONTINUED THE CASE WITH A SECOND SHEATH SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 8640620 ↗
• MalfunctionJul 20, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE NEEDLE LEAKS FROM THE SIDE OF THE HUB DURING A POPLITEAL ARTERIAL ACCESS WHEN USING THE IK DEVICE. WHEN IT IS ATTACHED TO A SYRINGE THE SALINE SQUIRTS OUT FROM THE SIDE. THE PROCEDURE OUTCOME WAS GOOD. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 7/3/18: THE PROCEDURE WAS COMPLETED USING THE DEVICE. THE DOCTOR DISCOVERED THE LEAK WHILE ATTEMPTING TO INJECT LIDOCAINE THROUGH THE ACCESS NEEDLE INTO THE SUBCUTANEOUS TISSUE. THE DOCTOR OPENED A SECOND DEVICE AND THE LUMEN OF THE NEEDLE WAS PATENT, THE WIRE PASSED THROUGH, AND THE SHEATH PASSED OVER THE WIRE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/17/18: THE SYRINGE WAS A 10ML B&D SYRINGE WITH LIDOCAINE. THE PLASTIC HUB OF THE NEEDLE NOT THE NEEDLE ITSELF WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705845 ↗
• MalfunctionJul 20, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE NEEDLE LEAKS FROM THE SIDE OF THE HUB DURING A POPLITEAL ARTERIAL ACCESS WHEN USING THE IK DEVICE. WHEN IT IS ATTACHED TO A SYRINGE THE SALINE SQUIRTS OUT FROM THE SIDE. THE PROCEDURE OUTCOME WAS GOOD. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 7/3/18: THE PROCEDURE WAS COMPLETED USING THE DEVICE. THE DOCTOR DISCOVERED THE LEAK WHILE ATTEMPTING TO INJECT LIDOCAINE THROUGH THE ACCESS NEEDLE INTO THE SUBCUTANEOUS TISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/17/18: THE SYRINGE WAS A 10ML B&D SYRINGE WITH LIDOCAINE. THE PLASTIC HUB OF THE NEEDLE NOT THE NEEDLE ITSELF WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705842 ↗
• MalfunctionMar 26, 2018Kinked; Kinked

  THE USER FACILITY REPORTED PER THE RT THE DILATOR WAS KINKED UPON REMOVAL FROM PACKAGE. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7369816 ↗