PINNACLE PRECISION ACCESS SYSTEM 70-5130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00389701010472), received between Aug 23, 2018 and Sep 15, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780966 ↗
• MalfunctionSep 19, 2018Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE EP (ELECTROPHYSIOLOGY) PHYSICIAN WAS USING A PRECISION DEVICE TO ACCESS A JUGULAR VEIN IN A PATIENT. THE PHYSICIAN GOT ACCESS AND TRIED TO PUT THE WIRE INTO THE NEEDLE HUB. THE WIRE WOULD NOT ENTER THE NEEDLE AND THEY COULD NOT GET THE WIRE TO ENTER NEEDLE TUBE. THEY THEN GOT A DIFFERENT NEEDLE AND GAINED ACCESS. THE PATIENT WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/6/2018: THE PATIENT WAS HAVING AN EP (ELECTROPHYSIOLOGY) PROCEDURE DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890727 ↗
• MalfunctionSep 13, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING PRODUCT EVALUATION OF THE RETURNED PRECISION DEVICE THERE WAS RESISTANCE THAT WAS FELT WHEN INSERTING THE GUIDEWIRE INTO THE NEEDLE. THE PATIENT THAT WAS INVOLVED WITH THE REPORTED DEVICE WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873597 ↗
• MalfunctionSep 13, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING PRODUCT EVALUATION OF THE RETURNED PRECISION DEVICE THERE WAS RESISTANCE THAT WAS FELT WHEN INSERTING THE GUIDEWIRE INTO THE NEEDLE. THE PATIENT THAT WAS INVOLVED WITH THE REPORTED DEVICE WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873595 ↗
• MalfunctionAug 23, 2018Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT DURING THE PROCEDURE THE NEEDLE IN THE PRECISION IK KIT WAS UNABLE TO ACCEPT THE WIRE AFTER ACCESS WAS GAINED. THE NEEDLE SEEMED TO BE STICKING UP INTO THE HUB SO THAT WHEN ACCESS WAS ACHIEVED THE WIRE DID NOT FUNNEL INTO THE NEEDLE TUBE. THE WIRE WOULD GO INTO THE HUB BUT WOULD THEN HIT THE SIDE OF THE NEEDLE TUBE. THE NEEDLE TUBE APPEARS TO NOT BE FLUSH WITH THE HUB, ALLOWING THE WIRE TO GO INTO THE HUB BUT NOT THE NEEDLE TUBE. THE PATIENT CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808720 ↗
• MalfunctionAug 23, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT DURING THE PROCEDURE THE NEEDLE IN THE PRECISION IK KIT WAS UNABLE TO ACCEPT THE WIRE AFTER ACCESS WAS GAINED. THE NEEDLE SEEMED TO BE STICKING UP INTO THE HUB SO THAT WHEN ACCESS WAS ACHIEVED THE WIRE DID NOT FUNNEL INTO THE NEEDLE TUBE. THE WIRE WOULD GO INTO THE HUB BUT WOULD THEN HIT THE SIDE OF THE NEEDLE TUBE. THE NEEDLE TUBE APPEARS TO NOT BE FLUSH WITH THE HUB, ALLOWING THE WIRE TO GO INTO THE HUB BUT NOT THE NEEDLE TUBE. THE PATIENT CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 8/20/18: THE PROCEDURE BEING PERFORMED WAS AN INTRAVASCULAR PROCEDURE VIA FEMORAL ACCESS. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND WHEN THE ISSUE WAS NOTED ANOTHER NEEDLE WAS PULLED AND USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808713 ↗