PRIORITYONE UG1602Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04543334177254), received between Aug 8, 2017 and Jul 19, 2024 — classified as 4 injuries, 7 malfunctions.

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

• InjuryJul 19, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE USER FACILITY REPORTED THE ASPIRATION CATHETER, PRIORITY ONE, WAS USED FOR A THROMBECTOMY. MULTIPLE ATTEMPTS WERE SUCCESSFUL (5-6 TIMES). THERE WAS MORE CLOT DISTALLY, SO THEY ADVANCED THE CATHETER BUT STUCK. WHEN PULLING IT, THE CATHETER'S TIP DISLODGED IN THE LEFT MAIN. AN ATTEMPT TO EXTRACT THE FRAGMENT WAS MADE WITHOUT SUCCESS, THEN IT MIGRATED TO THE THORAX.

  Patient problems: Foreign Body In Patient

  MAUDE report 19786023 ↗
• MalfunctionJul 19, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE USER FACILITY REPORTED THE ASPIRATION CATHETER, PRIORITY ONE, WAS USED FOR A THROMBECTOMY. MULTIPLE ATTEMPTS WERE SUCCESSFUL (5-6 TIMES). THERE WAS MORE CLOT DISTALLY, SO THEY ADVANCED THE CATHETER BUT STUCK. WHEN PULLING IT, THE CATHETER'S TIP DISLODGED IN THE LEFT MAIN. AN ATTEMPT TO EXTRACT THE FRAGMENT WAS MADE WITHOUT SUCCESS, THEN IT MIGRATED TO THE THORAX.

  Patient problems: Foreign Body In Patient

  MAUDE report 19786017 ↗
• InjuryJun 21, 2024Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated; Physical Resistance/Sticking

  AN INJURY WAS REPORTED IN A PATIENT WHO WAS IN THE CATHETERIZATION LAB FOR A NON-STEMI, WHERE AN ATTEMPT WAS MADE TO ASPIRATE A CLOT. USING A RIGHT RADIAL APPROACH WITH A 6F GUIDE EBU, A PCI WITH A 2.5MM BALLOON WAS PERFORMED. THE PRIORITY ONE CATHETER CROSSED, AND THE CLOT WAS ASPIRATED. HOWEVER, AS THE CATHETER WAS BEING WITHDRAWN FROM THE THIRD DIAGONAL, RESISTANCE WAS ENCOUNTERED, AND ADDITIONAL FORCE USED TO REMOVE IT CAUSED THE TIP ON P1 TO DISLODGE AND REMAIN INSIDE THE CORONARY ARTERY. THE PATIENT WAS STABLE BUT WAS TRANSFERRED TO THE UNIVERSITY OF KANSAS HOSPITAL FOR FURTHER INTERVENTION, WHICH WAS NOT PERFORMED AS THE PATIENT REMAINED STABLE. THE PROCEDURE CONDUCTED WAS A HEART CATHETERIZATION, WITH NO BLOOD LOSS REPORTED. THE PATIENT HAS A HISTORY OF CHEST PAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19581538 ↗
• MalfunctionMar 29, 2021Device Damaged Prior to Use; Device Fell

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION, PERIPHERAL VASCULAR DISEASE AND BRADYCARDIA. AFTER PRESENTING TO ED WITH INDIGESTION AND HEARTBURN, TAKEN TO INVASIVE CATH LAB FOR DIAGNOSTIC HEART CATH. THE PRIORITY ONE CATHETER WAS NOT SECURE IN THE LOOP WHEN TAKEN OUT OF THE PACKAGE. THE CATHETER FELL ONTO THE FLOOR; NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580944 ↗
• MalfunctionFeb 3, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WE LOADED THE CATHETER (WITH THE STYLET) OVER THE CORONARY WIRE. THEN, REMOVED STYLET AND HOOKED UP TO THE NEGATIVE SYRINGE. AS WE PULLED BACK, THE WIRE STARTED TO COME BACK AND FELT STUCK SO WE PULLED IT ALL OUT AND THE WIRE WAS KINKED AT THE PROXIMAL PORT. WE REWIRED AND TRIED ANOTHER CATHETER IN THE SAME WAY AND IT HAPPENED AGAIN. THE PATIENT CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS OK. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2020: THE PROCEDURE WAS A STEMI AND THIS EVENT OCCURRED AS THE DOCTOR ATTEMPTED TO DO ASPIRATION THROMBECTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9661412 ↗
• MalfunctionFeb 3, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WE LOADED THE CATHETER (WITH THE STYLET) OVER THE CORONARY WIRE. THEN, REMOVED STYLET AND HOOKED UP TO THE NEGATIVE SYRINGE. AS WE PULLED BACK, THE WIRE STARTED TO COME BACK AND FELT STUCK SO WE PULLED IT ALL OUT AND THE WIRE WAS KINKED AT THE PROXIMAL PORT. WE REWIRED AND TRIED ANOTHER CATHETER IN THE SAME WAY AND IT HAPPENED AGAIN. THE PATIENT CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS OK. ADDITIONAL INFORMATION WAS RECEIVED 14JANUARY2020: THE PROCEDURE WAS A STEMI AND THIS EVENT OCCURRED AS THE DOCTOR ATTEMPTED TO DO ASPIRATION THROMBECTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9661404 ↗
• MalfunctionMar 4, 2019Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT WHEN THE USER WAS USING THE ELIMINATE, THE GUIDEWIRE WAS TRAPPED AND STACKED. THEREFORE THE ELIMINATE STOPPED MOVING, AND ANOTHER PRODUCT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387692 ↗
• InjuryDec 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS USING THE PRIORITYONE ASPIRATION CATHETER FOR A THROMBUS REMOVAL FROM THE RIGHT CORONARY ARTERY. UPON THE SECOND PASS OF THE DEVICE , THE DEVICE WAS DIFFICULT TO REMOVE. WHEN ATTEMPTING TO REMOVE THE DEVICE, A DISSECTION WAS CAUSED IN THE RIGHT CORONARY ARTERY (HOWEVER, THIS WAS A CHRONIC TOTAL OCCLUSION). WHEN INSPECTING THE DEVICE AFTER REMOVAL, THE DOCTOR NOTICED THE TIP OF THE CATHETER WAS NO LONGER ATTACHED. WHEN LOOKING ON FLUORO, HE NOTICED THE RIP(TIP) WAS IN THE RIGHT CORONARY ARTERY. IT WAS NOT RETRIEVED AND IS IN THE MARGINAL BRANCH OF THE ARTERY. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION RECEIVED ON 11/29/2018: NO TREATMENT EXPECTED FOR THE PATIENT, THE TIP WAS NOT RETRIEVED. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8184896 ↗
• MalfunctionNov 13, 2018Material Puncture/Hole; Material Puncture/Hole

  THE USER FACILITY REPORTED THAT WHEN THE WIRE WAS PULLED BACK IT WENT THROUGH THE SIDE OF THE TC CATHETER. THIS OCCURRED DURING A PERCUTANEOUS CORONARY INTERVENTION OF THE POSTERIOR LATERAL BRANCH. THERE WAS NO BLOOD LOSS REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8064665 ↗
• InjuryOct 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT RADIOPAQUE TIP CAME OFF THE TIP OF THE PRIORITYONE ASPIRATION CATHETER IN THE DISTAL RCA (RIGHT CORONARY ARTERY). THE TIP THEN DISLODGED FROM THE RCA (RIGHT CORONARY ARTERY), MOVED TO THE AORTA, AND THEN TO THE DISTAL LAD (LEFT ANTERIOR DESCENDING). IT WAS THEN PUSHED TO THE DISTAL CTO (CHRONIC TOTAL OCCLUSION) CAP AND WAS LEFT IN THE PATIENT. THE TIP WAS PUSHED TO THE DISTAL CTO CAP VIA A WIRE. THE TIP REMAINED IN THE PATIENT. THE PATIENT WAS STABLE AND WAS RELEASED FROM HOSPITAL PER PROTOCOL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7929389 ↗
• MalfunctionAug 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THE CATHETER MALFUNCTIONED DURING A CASE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PATIENT IS FINE. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6773117 ↗