PINNACLE PRECISION ACCESS SYSTEM 70-5160Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00389701010779), received between Jan 20, 2017 and Mar 12, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMar 20, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE PRECISION ACCESS WIRE WAS RETAINED IN THE PATIENT'S LEG. THE WIRE WAS SHORN BY THE NEEDLE AND UNRAVELED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PROCEDURE PERFORMED WAS A RIGHT AND LEFT HEART CATHETERIZATION VIA FEMORAL ARTERY AND VEIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS INTENDED WITH THE TERUMO DEVICE. THE WIRE TIP WAS UNABLE TO BE REMOVED. THEY BELIEVE IT WAS EXTRAVASCULAR, AS THEY COULD NOT SNARE IT FROM THE CONTRALATERAL ARTERY. NO OTHER INTERVENTION WAS REQUIRED. THERE WAS NO ESTIMATED BLOOD LOSS (EBL) RELATED TO THE RETAINED WIRE FRAGMENT. THE ESTIMATED BLOOD LOSS (EBL) FOR THE PROCEDURE WAS APPROXIMATELY 5CC. THE PATIENT WAS STABLE AND AT HOME. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13833991 ↗
• MalfunctionOct 3, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THE PRECISION DEVICE WIRE WAS KINKED AND WAS STUCK AT THE END OF THE NEEDLE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED 10 SEPTEMBER 2019: THE PROCEDURE PERFORMED WAS A LEG ANGIO. THE DEVICE WAS USED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED 12 SEPTEMBER 2019: IT WAS REPORTED THAT IT COULD HAVE BEEN THE ANATOMY AS THE COOK MICROCATHETER WIRE WAS BENT BUT THE PRECISION WIRE ACCORDION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150450 ↗
• InjuryApr 17, 2019Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PHYSICIAN GAINED COMMON FEMORAL ACCESS WITH THE PRECISION ACCESS NEEDLE, INSERTED NITINOL .021 WIRE THROUGH NEEDLE, DURING A RADIAL ACCESS CASE. WHEN ATTEMPTING TO DRAW BACK THE WIRE TO REDIRECT POSITION THE PHYSICIAN NOTED SIGNIFICANT "CATCHING", PREVENTING HIM FROM SMOOTHLY PULLING THE WIRE BACK. AFTER A COUPLE OF ATTEMPTS TO RETRACT THE WIRE, HE WAS ABLE TO GET THE WIRE OUT; HOWEVER, HE NOTED UPON REMOVAL THAT THE STAINLESS STEEL OUTER PORTION OF THE WIRE HAD STRIPPED OFF OF THE DISTAL TIP OF THE WIRE. UPON ANGIOGRAPHY THE PHYSICIAN FOUND A SMALL PIECE OF THE WIRE PRESENT IN THE COMMON FEMORAL. IT WAS LEFT IN THE PATIENT AS ITS TOO DIFFICULT TO RETRIEVE. THE PHYSICIAN REPORTED THAT DESPITE THE WIRE ISSUE, HE WAS STILL ABLE TO SUBSEQUENTLY GAIN ACCESS AND PERFORMED PERIPHERAL INTERVENTION WITHOUT ISSUES. THE PATIENT WAS REPORTED TO BE STABLE CONDITION, AND THE CASE WAS COMPLETED WITH NO COMPLICATIONS. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8523357 ↗
• InjuryApr 16, 2019Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PHYSICIAN ATTEMPTED TO GAIN ACCESS WITH A 5FR PINNACLE PRECISION ACCESS KIT NEEDLE/NITINOL WIRE, DURING A RADIAL ACCESS CASE. THE NEEDLE WAS INSERTED FOLLOWED BY THE WIRE, THE PHYSICIAN ATTEMPTED TO RE-POSITION THE WIRE AND DREW THE WIRE BACK THROUGH THE NEEDLE. WHEN ATTEMPTING TO DRAW THE WIRE BACK, HE FELT A CATCH WHICH PREVENTED HIM FROM PULLING THE WIRE BACK ANY FURTHER. HE PULLED, AND THE WIRE CAME BACK; HOWEVER, IT THE DISTAL END OF THE WIRE WAS FOUND TO BE MISSING. UNDER ANGIOGRAPHY THE DISTAL WIRE TIP WAS SEEN NEAR/WITHIN THE PREVIOUSLY PLACED STENT IN THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN DEPLOYED AN ADDITIONAL BALLOON EXPANDABLE STENT TO PREVENT THE WIRE FROM MIGRATING. THE DEPLOYMENT WAS SUCCESSFUL AND THE WIRE WAS TRAPPED BETWEEN THE TWO STENTS. THE CASE WAS COMPLETED WITHOUT ISSUE AND THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 4, 2019. THE PROCEDURE PERFORMED WAS A RADIAL ACCESS CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8517734 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN RESPONSE TO USER FACILITY MEDWATCH REPORT # MW5084318 WAS RECEIVED FROM THE FDA ON MARCH 11, 2019. THE EVENT DESCRIPTION STATES THE FOLLOWING: A PATIENT WAS ADMITTED WITH A RIGHT LOWER LEG CLAUDICATION FOR ANGIOGRAPHY AND A POSSIBLE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY), ACCESS VIA THE LEFT FEMORAL ARTERY, WAS TECHNICALLY CHALLENGING. DUE TO THE EXTENSIVELY CALCIFIED VESSELS, RESULTING IN RETENTION OF THE DISTAL TIP OF THE ANGIOGRAPHY MICROWIRE. THE PATIENT WILL UNDERGO A RIGHT LOWER EXTREMITY ENDARTECTOMY (TO ADDRESS CLAUDICATION) WITH OPEN SURGICAL REMOVAL OF THE MICROWIRE AT A FUTURE DATE. THE PATIENT WAS HOSPITALIZED WITH A SURGICAL FOLLOW UP PLANNED.

  Patient problems: Claudication

  MAUDE report 8452619 ↗
• MalfunctionDec 14, 2018Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED AFTER GAINING ACCESS WITH THE NEEDLE INTO THE RIGHT FEMORAL ARTERY, THE WIRE BECAME TIGHT WITHIN THE NEEDLE UPON TRYING TO REDIRECT THE WIRE. THE WIRE AND NEEDLE WERE REMOVED AS ONE. THE WIRE WAS FELT TO HAVE A SNAG IN THE COIL. A SEPARATE WIRE WAS DROPPED AND ACCESS WAS OBTAINED AGAIN USING THE SAME NEEDLE. THE SECOND WIRE ADVANCED AND THE NEEDLE WAS THEN REMOVED. THE SHEATH WAS INSERTED AND THE CASE WAS ABLE TO BE COMPLETED. THE BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION (B)(6) 2018: THE PROCEDURE BEING PERFORMED WAS A LEFT HEART CATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166464 ↗
• MalfunctionAug 31, 2018Break; Break

  THE USER FACILITY REPORTED THAT DURING THE INITIAL ENTRY OF THE WIRE INTO THE NEEDLE USING A PRECISION DEVICE, THE WIRE STARTED COMING APART AND THE COILS STRETCHED APART. THE PHYSICIAN DID NOT REMOVE AND REINSERT MULTIPLE TIMES AND IT OCCURRED RIGHT AWAY. ANOTHER WIRE WAS USED SUCCESSFULLY AFTER THE ISSUE WAS NOTED. THE PATIENT WAS FINE AND STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. NO OTHER EQUIPMENT OR DEVICES WERE BEING USED WITH THE PRECISION KIT. ADDITIONAL INFORMATION WAS RECEIVED ON 8/22/2018: THE PROCEDURE BEING PERFORMED WAS A RUN-OFF / PERIPHERAL ANGIO. ACCESS WAS ON THE RIGHT FEMORAL ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837823 ↗
• InjuryMay 7, 2018Break; Break

  THE USER FACILITY REPORTED BREAKAGE ON THE INVOLVED IK: PRECISION DEVICE. THE MD WAS ATTEMPTING TO GET ACCESS WITH THE PRECISION NEEDLE AND WIRE. THE PATIENT BEGAN TO LIFT THEIR HEAD AND BEND AT THE KNEE. THE PHYSICIAN TRIED TO PULL BACK ON THE WIRE AND COULD NOT. THE NEEDLE WAS REMOVED AND THE WIRE WAS STILL IN PLACE. UNDER X-RAY IT WAS NOTED THE WIRE WAS A BIT "TANGLED". THE SUGGESTION WAS MADE TO USE THE DILATOR INSTEAD OF THE NEEDLE TO TRY TO SAFELY REMOVE THE WIRE. THE WIRE BROKE AND THE DILATOR HAD TO BE REMOVED. THE WIRE WAS STILL HANGING OUT FROM THE TRACT. THAT WIRE THAT WAS HANGING OUT WAS GENTLY PULLED ON BY THE PHYSICIAN AND IT ALSO BROKE LEAVING A SMALL PORTION OF THE WIRE STILL IN THE TISSUE TRACT. A SECOND PRECISION SHEATH WAS USED TO GAIN ACCESS. THE CASE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THE VASCULAR SURGERY WAS CONSULTED REGARDING THE WIRE THAT WAS LEFT IN THE BODY. ESTIMATED BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. THE PATIENT WAS REPORTED TO BE STABLE. THE PROCEDURE WAS SUCCESSFUL WITH THE USE OF A SECOND PRECISION SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 4/27/18. IT WAS REPORTED THAT THE PHYSICIAN SEEN THE PATIENT IN THE OFFICE AND THE PATIEN

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 7489881 ↗
• MalfunctionFeb 14, 2018Break; Break

  THE USER FACILITY REPORTED THE DILATOR HUB OR HANDLE BROKE OFF FROM THE SHEATH AS THE MD TRIED TO REMOVE DILATOR AFTER THE SHEATH INSERTION. THE MD HAD TO REMOVE THE DILATOR WITH SURGICAL FORCEPS. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 24, 2018. IT WAS A PERIPHERAL ANGIOPLASTY PROCEDURE. THERE WAS NO BLOOD LOSS OR NEGATIVE OUTCOME OF THE PROCEDURE ITSELF. NO PIECES OR FRAGMENTS WERE LEFT BEHIND, THE PHYSICIAN WAS ABLE TO GRASP THE BROKEN PIECE OF DILATOR WITH SOME FORCEPS AND HE PULLED OUT THE COMPLETE DILATOR. IT SEEMED LIKE THE HUB ASSEMBLY FROM THE DILATOR JUST SNAPPED OFF AT THE BASE. THE SHEATH PERFORMED AS INTENDED AFTER THE DILATOR WAS REMOVED, AND THERE WERE NO ISSUES OR LEAKS, JUST THE INITIAL FAILURE WHEN IT SNAPPED OFF UPON ENTRY INTO THE COMMON FEMORAL ARTERY AS THE PHYSICIAN WAS REMOVING THE WIRE AND DILATOR AFTER GETTING ACCESS. THERE WERE OTHER CATHETERS AND EQUIPMENT USED AFTER THE SHEATH WAS INSERTED. THE PATIENT WAS REPORTED TO BE STABLE AND THE PROCEDURE OUTCOME WAS POSITIVE. THE SCRUB TECH DISPOSED THE DILATOR AND THE BROKEN OFF HUB ASSEMBLY INTO A BIO HAZARD BAG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269782 ↗
• InjurySep 7, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OFF THE WIRE FOR THE PRECISION SHEATH BROKE OFF IN THE TISSUE TRACT OF THE LEG. IT WAS REPORTED THAT IT WAS NOT IN THE ARTERY AND THAT THEY MOVED THE NEEDLE AROUND TRYING TO REPOSITION THE WIRE, AND FELT LIKE IT MUST HAVE DAMAGED THE WIRE. IT WAS REPORTED THAT THE PATIENT CONDITION WAS GOOD. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS GOOD. IT WAS REPORTED THAT THERE WAS NO EXCESSIVE BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 8/17/17 - THE TIP OF THE WIRE WAS LEFT IN THE PATIENT AS IT WAS NOT ANYWHERE NEAR THE ARTERY. IT WAS REPORTED THAT IT APPEARED TO BE IN THE MUSCLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6849260 ↗
• MalfunctionJul 14, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT UPON REMOVAL OF THE SHEATH THE DILATOR SNAPPED OFF. ALL PIECES WERE RETRIEVED AND NO ADVERSE EVENT OR HARM WAS DONE TO THE PATIENT. THE DOCTOR WAS THE PERSON WHO REMOVED IT. THE PATIENT IS STABLE. THE PROCEDURE OUTCOME WAS NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6715119 ↗
• MalfunctionMar 30, 2017Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THE WIRE UNRAVELED DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE WIRE UNRAVELED DURING ACCESS WITH PINNACLE PRECISION KIT; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS REPORTED AS DOING OKAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446477 ↗
• MalfunctionJan 20, 2017Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE SEPARATED DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PHYSICIAN WENT TO PULL THE INTRODUCER OUT OF SHEATH; THE TOP OF THE INTRODUCER CAME OFF; THE INTRODUCER STAYED IN THE SHEATH; PHYSICIAN WAS ABLE TO PULL THE INTRODUCER OUT; AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6266451 ↗