PhenomTM 21 Catheter FG13160-0615-1S (UDI 00763000399696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000399696), received between Aug 31, 2023 and Apr 20, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Retraction Problem

  NO NEW EVENT INFORMATION. PHENOM 21 MICROCATHETER DEVICE INFORMATION PROVIDED THAT THE LOT NUMBER WAS 231520626.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933041 ↗
• MalfunctionOct 15, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY; HOWEVER, THE DEVICE COULD NOT BE RESHEATHED TO REPOSITION. ADDITIONALLY, IT WAS CLARIFIED THAT THE THIRD ATTEMPT AT TREATMENT WAS SUCCESSFUL WITH THE PHENOM 027 AND PIPELINE SHIELD, NOT WITH VANTAGE AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294176 ↗
• MalfunctionJul 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR MIDDLE CEREBRAL ARTERY (MCA) ISCHEMIC CEREBRAL (IC) INFARCTION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENT'S PRE-OPERATIVE TICI SCORE WAS 1, AND THE POST-OPERATIVE TICI SCORE IMPROVED TO 2B. THE PATIENT WAS TREATED WITH A THROMBECTOMY PROCEDURE USING A TPS (THROMBECTOMY PLATFORM SYSTEM). THE SOLITAIRE DEVICE WAS USED, WITH ZERO PASSES PERFORMED DURING THE PROCEDURE. THE TIME REQUIRED FROM THE ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS 30 MINUTES. IT WAS REPORTED THAT THE PHENOM 21 AND SOLITAIRE WERE SELECTED. THE DEGREE OF VASCULAR TORTUOSITY LEADING TO THE MCA WAS MODERATE. THE OPTIMO 9FR WAS DELIVERED TO THE IC, AND THE PHENOM 21 WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CHIKAI 14 WIRE, WHICH WAS ALSO PREPARED ACCORDING TO THE IFU, WAS SET UP. AFTER DELIVERING THE PHENOM 21 TO THE OCCLUSION SITE, AN ATTEMPT WAS MADE TO DELIVER THE SOLITAIRE STENT, WHICH HAD BEEN PREPARED ACCORDING TO THE IFU, INTO THE PHENOM 21. HOWEVER, STRONG RESISTANCE AND STIFFNESS WERE FELT. DESPITE SENSING ABNORMALITIES IN BOTH THE PHENOM 21 AND THE SOLITAIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486207 ↗
• MalfunctionMay 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIREX6-40 ENCOUNTERED RESISTANCE IN THE DISTAL SHAFT OF THE PHENOM. STENT DISCONNECTION WAS ALSO NOTED AS THE SOLITAIRE DELIVERY PUSHER BECAME DISCONNECTED WHEN IT WAS PULLED INTO THE PHENOM OUTSIDE THE BODY. THE PATIENT WAS UNDERGOING THROMBECTOMY FOR TREATMENT OF AN ISCHEMIC CEREBRAL INFARCTION IN THE RIGHT M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA)/INTERNAL CAROTID ARTERY (ICA) WITH A 2-5MM DIAMETER. TICI (POSTOPERATIVE): NO PROBLEMS. THE PATIENT WAS TREATED WITH A TPS. THERE WERE 2 PASSES FOR THE SOLITAIRE. TIME REQUIRED FROM ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS ABOUT 1 HOUR. IT WAS REPORTED THAT AFTER THE PRODUCT WAS DEPLOYED TO THE RIGHT M1 AND SUCCESSFUL REVASCULARIZATION WAS ACHIEVED, IT WAS DEPLOYED AT THE OCCLUSION OF THE RIGHT ICA AND THE SOLITAIREX WAS COLLECTED INTO THE PHENOM 21. HOWEVER, WHEN THE SOLITAIREX WAS ABOUT HALFWAY INSERTED INTO THE PHENOM 21, IT BECAME IMPOSSIBLE TO RETRACT IT. DURING SURGERY, IT WAS COLLECTED AS IS AND THE PROCEDURE WAS COMPLETED, BUT WHEN IT WAS PULLED INTO THE PHENOM 21 OUTSIDE THE BODY, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035949 ↗
• MalfunctionMay 21, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE WAS STUCK IN A PHENON 21 CATHETER. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION WITH A FLOW DIVERTER PIPELINE. DURING THE PASSAGE OF THE FIRST STENT IN THE PHENOM 21 CATHETER THE PASSAGE WAS OBSERVED TO BE BLOCKED, MAKING IT IMPOSSIBLE TO CONTINUE PROGRESSION IN THE CATHETER. IT WAS COMPLETELY LOCKED IN THE CATHETER MAKING IT IMPOSSIBLE TO BE REMOVED EVEN USING EXTRA FORCE. IT WAS DECIDED TO REMOVE THE CATHETER AND STENT. THE PROCEDURE WAS RESTARTED WITH A NEW PHENOM 21 CATHETER AND STENT IF THE SAME SIZE WITH PERFECT PASSAGE WITHOUT FRICTION. THE CATHETER RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS DAMAGED IN THE MIDDLE SECTION. THE PUSHWIRE WAS NOT DAMAGED. THE DEIVCES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANUERYSM IN THE ACM LOCATION. HE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 7MM. THE DISTAL LANDING ZONE WAS 2.3MM AND THE PROXIMAL LANDING ZONE WAS 2.2MM. VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL DIAMETER WAS 2.5MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19364600 ↗
• MalfunctionMar 14, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE X EXPERIENCED RESISTANCE AT THE PHENOM 21 MICROCATHETER HUB DURING PREPARATION. THEY TRIED SEVERAL TIMES SLOWLY, BUT THE DEVICE COULD NOT ENTER THE CATHETER. THE SOLITAIRE WAS DAMAGED IN THE PHENOM CATHETER HUB, AND THE HUB OF THE CATHETER WAS CRACKED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE DISTAL PART OF SOLITAIRE WAS DAMAGED. FOR THE CAUSE OF THE EVENT IT WAS REPORTED THAT, "WE GUESS IT'S A PHENOM PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909431 ↗
• MalfunctionAug 31, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER DELAMINATION OCCURRED DURING IN-HOUSE SIMULATED USE BENCHTOP TESTING. CATHETER DELAMINATION WAS OBSERVED DURING IN-HOUSE BENCHTOP TESTING BY MEDTRONIC ENGINEERS. THERE WERE NO PATENTS OR HCPS INVOLVED IN THE EVENT. THERE WERE NO KINKS ON THE PUSHWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667555 ↗