PINNACLE PRECISION ACCESS SYSTEM 70-8160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701010809), received between Jan 11, 2022 and Oct 31, 2025 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJan 11, 2022Break; Difficult to Insert; Physical Resistance/Sticking; Break; Difficult to Insert; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT DURING AN ANIMAL STUDY, WHILE ATTEMPTING TO GET ACCESS IN THE FEMORAL ARTERY, THERE WAS RESISTANCE INSERTING THE WIRE THROUGH THE NEEDLE. WHEN REMOVING THE WIRE THERE WAS ALSO SOME RESISTANCE. ONCE THE WIRE WAS OUT OF THE BODY, IT WAS NOTICED THAT THE WIRE TIP WAS SHEARED OFF. THE RESIDUAL WIRE WAS SEEN ON ULTRASOUND AND FLUOROSCOPY. THE WIRE APPEARED OUTSIDE OF THE ARTERY (IN THE TISSUE TRACK) ON ULTRASOUND. A 5FR PINNACLE PRECISION WAS USED. THE VESSEL SIZE WAS INITIALLY APPROXIMATELY 5MM. THE VESSEL WAS HEALTHY AND WITHOUT DISEASE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13232519 ↗