MarksmanTM FA-55150-1030 (UDI 00847536008328)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536008328), received between Nov 15, 2018 and Feb 10, 2020 — classified as 2 injuries, 1 malfunction.

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

• InjuryFeb 10, 2020Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED VASOSPASMS. NIMODIPINE WAS ADMINISTERED FOR 10 MINUTES TO TREAT THE VASOSPASM. THE PROCEDURE WAS COMPLETED VIA STENT ASSISTED COILING. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED, SACCULAR INTERNAL CAROTID ARTERY ANEURYSM. MEASURING 5.5 MM X 6 MM, LANDING ZONE DISTAL 3.9 MM PROXIMAL 3.7 MM. THE VESSEL ANATOMY WAS MODERATELY TORTUOUS.

  Patient problems: Vasoconstriction

  MAUDE report 9686446 ↗
• InjurySep 16, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT A CAVERNOUS CAROTID FISTULA (CCF) WAS DEVELOPED DURING INTERVENTION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM IN THE COMMUNICATING SEGMENT. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, A NAVIEN 5F WAS PLACED SUCCESSFULLY. AFTERWARD, A MARKSMAN AND AVIGO GUIDE WIRE WERE PLACED ACROSS THE ANEURYSM WITHOUT ISSUE. THE FLUSH LINE WAS CONNECTED TO THE MICROCATHETER AND A PIPELINE FLEX WAS SELECTED. THE PIPELINE FLEX WAS PLACED IN THE HEMOSTATIC VALVE TO ALLOW HYDRATION. THE PIPELINE FLEX WAS ADVANCED THROUGH THE MARKSMAN WITH NOTED DIFFICULTY. WHEN THE PIPELINE FLEX REACHED THE DISTAL END OF THE MARKSMAN, IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO DEPLOY THE DEVICE WITHOUT SUCCESS. THE PIPELINE FLEX WAS ATTEMPTED TO BE RETRACTED. IN THE PROCESS OF REMOVAL, IT WAS REPORTED THAT "SINCE ON THE PART THAT LAY OUTSIDE THE PATIENT, THE MARKSMAN BROKE FREEING THE FLOW DIVERTER ON THE PATIENT'S SURGICAL CLOTHING." AFTERWARD, A CONTROL ANGIOGRAM WAS PERFORMED REVEALING A CAVERNOUS CAROTID FISTULA (CCF). IT WAS REPORTED THAT THE CCF OCCURRE

  Patient problems: Fistula

  MAUDE report 9072677 ↗
• MalfunctionNov 15, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT AN ACUTE INTERNAL CAROTID (IC) OCCLUSION ISCHEMIC STROKE CASE, THERE WAS RESISTANCE WHEN THE SOLITAIRE PLATINUM 6-40 WAS ADVANCE AS THE BGC AND THE PENUMBRA CATHETERS WERE KINKED. THERE WAS ALSO RESISTANCE WHEN THE REPLACEMENT SOLITAIRE AND MARKSMAN WERE RETRIEVED INTO THE PENUMBRA ACE CATHETER. OPTIMO 9FR WAS DELIVERED TO CCA, PENUMBRA ACE WAS DELIVERED CLOSE TO OCCLUSION, THE MARKSMAN WAS DELIVERED INTO THE MIDDLE CEREBRAL ARTERY (MCA), AND SOLITAIRE PLATINUM (6 * 40) WAS ATTEMPTED TO BE DELIVERED. HOWEVER, THE BGC AND THE ACE WERE KINKING, WHICH CAUSED EXTREMELY DIFFICULT TO DELIVER SOLITAIRE 6 * 40. THE SOLITAIRE 6 * 40 WAS NOT ABLE TO BE DELIVERED TO THE TIP OF MARKSMAN. A NEW SOLITAIRE PLATINUM 4 * 20 WAS DELIVERED. WHEN THE SOLITAIRE 4 * 20 AND MARKSMAN WERE RETRIEVED INTO THE ACE CATHETER STRONG RESISTANCE WAS FELT. THE POSITION OF THE TIP OF ACE WAS NOT CHANGED, THE SOLITAIRE AND MARKSMAN WERE REMOVED OUT OF THE BODY UNDER SUCTIONING WITH THE AID OF THE ACE. AT THAT TIME, IT WAS FOUND THAT MARKSMAN'S TIP WAS BROKEN. WHEN CHECKING INSIDE THE ACE 'S CANISTER PUMP, THE TIP OF MARKSMAN (ABOUT 22 CM) HAD BEEN ¿SUCKED¿ / ASPIRATED OUT OF THE PATIEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073725 ↗