PhenomTM Plus Catheter FG19120-1030-1S (UDI 00763000399733)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000399733), received between Aug 9, 2021 and Aug 15, 2025 — classified as 2 deaths, 3 injuries, 6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE ACCESSORY ITEMS OR DEVICES WERE NOT NOTED TO HAVE BEEN DAMAGED PRIOR TO USE. THERE WAS NO FRICTION OR DIFFICULTY ENCOUNTERED DURING DELIVERY OR REMOVAL. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE CAUSE OF THE MARKER BAND SEPARATION WAS NOT DETERMINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22821904 ↗
• MalfunctionAug 4, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE AND KINK WAS NOT DETERMINED. THE PHENOM CATHETER HAD BEEN INSERTED INTO THE PATIENT. PATIENT HAD NO HEALTH DAMAGES AT ALL. RESISTANCE AT THE SERPENTINE SITE WAS CONFIRMED. CATHETER DAMAGE COULD NOT BE CONFIRMED BY FLUOROSCOPY, BUT WAS CONFIRMED AFTER COLLECTION. THERE WAS SOME RESISTANCE AT THE DEVICE PASSING. NO PATIENT SYMPTOMS WERE ASSOCIATED WITH THE USE OF THE DAMAGED CATHETER. A MICROCATHETER HAD BEEN INSERTED INTO THE PHENOM CATHETER PRIOR TO OBSERVING THE DAMAGE. ANY ABNORMALITIES AT THE DISTAL SHAFT COULD NOT BE CONFIRMED WITH FLUOROSCOPY. THE GUIDEWIRE WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708506 ↗
• MalfunctionFeb 6, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY, THE DEVICE BECAME STUCK DURING RESHEATHING IN THE DISTAL SECTION OF THE PHENOM 27 MICROCATHETER. THE CATHETER, SPECIFICALLY THE DISTAL SECTION, EXPERIENCED RESISTANCE AND WAS FOUND TO BE DAMAGED, DESCRIBED AS FLATTENED AND KINKED. ADDITIONALLY, RESISTANCE WAS ENCOUNTERED IN THE MIDDLE SECTION OF THE PHENOM PLUS CATHETER USED IN THE PROCEDURE. THE PROCEDURE INVOLVED TREATING AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY, WITH SEVERE VESSEL TORTUOSITY NOTED. THE MAX DIAMETER AND NECK DIAMETER WERE 5MM. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.5MM PROXIMAL. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY WITH A DIAMETER OF 5MM OR ABOVE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ANGIOGRAPHIC RESULT POST-PROCEDURE APPEARED SATISFACTORY. THE PHYSICIAN ATTEMPTED TO RELEASE THE LOAD IN THE SYSTEM TO RESOLVE THE ISSUE, BUT IT WAS UNSUCCESSFUL. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. THE TRI-AXIAL SYSTEM WAS INITIALLY POSITIONED CORRECTLY, BUT AS THE DEVICE WAS MANEUVERED, THE VANTAGE DEVICE BEGAN TO RIBBON OR FLATTEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322665 ↗
• MalfunctionNov 14, 2024

  MICROCATHETER TIP BROKE OFF INTO THE CATHETER. CATHETER WAS REMOVED WITH THE BROKEN TIP INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682955 ↗
• InjuryApr 19, 2024Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A RIST CATHETER ENCOUNTERED RESISTANCE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A PICA ANEURYSM OFF THE LEFT VERTEBRAL ARTERY WITH THE OFF LABEL USE OF A PIPELINE SHIELD 2X10. RIGHT RADIAL ACCESS VIA A 6FR. GLIDESHEATH SLENDER (TERUMO) WITH 6FR. RIST 100 CM POSITIONED INTO LEFT VERTEBRAL ARTERY (MINIMAL "TORTUOSITY") WITHOUT ISSUE. THE HEALTHCARE PROVIDER DECIDED TO ADD A PHENOM PLUS INTERMEDIATE CATHETER FOR ADDITIONAL SUPPORT TO INTERVENE WITH A PIPELINE SHIELD FOR THE TREATMENT OF THE PICA ANEURYSM. THERE WAS RESISTANCE ENCOUNTERED AT THE DISTAL 2/3RDS OF THE RIST GUIDE AS THE PHENOM PLUS WAS ADVANCED THROUGH THE RIST AS RESISTANCE WAS NOTED. RETRACTING BACK THE PHENOM PLUS AND ATTEMPTING TO REPOSITION THE RIST GUIDE TO ADDRESS THE "KINK" FOLLOWED BY READVANCING THE PHENOM PLUS WAS SUCCESSFUL ALTHOUGH SLIGHT RESISTANCE WAS STILL ENCOUNTERED. ONCE THE PHENOM PLUS INTERMEDIATE CATHETER WAS SUCCESSFULLY PLACED FOR SUPPORT OF THE PICA ANEURYSM TREATMENT WITH PIPELINE SHIELD 2.5X10 AN ANGIOGRAPHIC PICTURE WAS TAKEN TO DOCUMENT CATHETER PLACEMENT. THE ANGIO

  Patient problems: Foreign Body In Patient

  MAUDE report 19147725 ↗
• InjuryApr 4, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT  THE PATIENT WAS BEING TREATED FOR VASOSPASM IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA). THE PHENOM PLUS WAS PARKED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). A SCEPTER BALLOON WAS PLACED THROUGH THE PHENOM PLUS AND PARKED IN THE ACA. THE PHYSICIAN REMOVED THE PHENOM PLUS AND THE SCEPTER FROM THE PATIENT. WHEN THE PHYSICAN ATTEMPTED TO ADVANCE THE PHENOM PLUS BACK UP INTO THE ICA THE PHYSICIAN NOTICED THAT HE COULD NOT SEE THE TIP OF THE PHENOM PLUS. THE PLUS WAS REMOVED AND NOTED THAT THE TIP WAS GONE. THE TIP FLOATED OUT INTO THE RIGHT M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE MARKER BAND DISLODGED. THE CATHETER TIP WAS NOT SHAPED. THE MARKER BAND REMAINS IN THE PATIENT'S M4. THERE WAS SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THEY ATTEMPTED TO RETRIEVE THE TIP WITH ASPIRATION CATHETER (RED 43) AND A MICROCATHETER (SL10) BUT WERE UNSUCCESSFUL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT RIGHT MIDDLE CEREBRAL ARTERY (MCA) VASO

  Patient problems: Foreign Body In Patient

  MAUDE report 19042182 ↗
• DeathAug 31, 2023No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT PRESENTED WITH A GIANT ANEURYSM. THE PHYSICIAN TREATED IT BY PLACING TWO STRYKER COILS IN THE ANEURYSM AND LAID A PIPELINE SHIELD ACROSS THE NECK OF THE ANEURYSM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN AND PLAVIX. ON (B)(6) 2023 THE PATIENT RETURNED TO THE HOSPITAL IN THE EMERGENCY ROOM WITH A SUBARACHNOID HEMORRHAGE. THE PATIENT WAS BROUGHT TO INTERNAL RADIATION FOR IMAGING AND FOUND TO HAVE RUPTURED THE PREVIOUSLY TREATED ANEURYSM. THE PHYSICIAN THEN PLACED TWO MORE PIPELINE SHIELD DEVICES ACROSS THE NECK OF THE ANEURYSM TO TRY AND STOP THE BLEEDING. ON (B)(6) 2023 THE PATIENT CLOTTED OFF THEIR PARENT VESSEL WHERE THE TWO ADDITIONAL PIPELINES HAD BEEN PLACED. MANY ATTEMPTS WERE MADE TO CLEAR THE CLOT BUT THEY WERE NOT SUCCESSFUL. THE PATIENT PASSED AWAY ON (B)(6) 2023. THE PIPELINES WERE NOT USED FOR AN OFF-LABEL USE. THE PIPELINE DEVICES AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 25MM AND A 10MM NECK DIAMETER. THE L

  Patient problems: Intracranial Hemorrhage; Obstruction/Occlusion; Rupture

  MAUDE report 17664792 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHENOM PLUS MAKER BAND WHEN REMOVED WAS DISLODGED IN THE TUOHY BORE. INJECTION AFTERWARDS WITH BASE CATHETER SHOWS MARKER BAND SHEERED OFF INTO DISTAL ANATOMY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17608349 ↗
• DeathMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT PASSED AWAY FOLLOWING A PROCEDURE INVOLVING A PIPELINE, RIST CATHETER, PHENOM PLUS CATHETER, AND PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, BLISTER ANEURYSM LOCATED IN THE COMMUNICATING SEGMENT OF THE DISTAL RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 3.4MM, AND THE NECK DIAMETER WAS 4.5MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE WAS 3.05MM DISTAL AND 3.4MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 179. IT WAS REPORTED THAT THE MICROCATHETER SYSTEM WAS NAVIGATED TO THE M2 DIVISION AND THE PIPELINE WAS LOADED INTO THE SYSTEM FOR DEPLOYMENT. DEPLOYMENT WAS UNEVENTFUL, WITH NORMAL OPENING AND PLACEMENT. UTILIZING FOLLOW UP IMAGING, THE PHYSICIAN DETERMINED THAT PROXIMAL AND DISTAL COVERAGE WERE ADEQUATE AND THE PROCEDURE WAS COMPLETED. A SECOND ANGIOGRAPHIC STUDY WAS COMPLETED THE FOLLOWING DAY TO ENSURE PLACEMENT AND PATENCY WERE UNCHANGED. DEVICE PLACEMENT AND PATENCY WERE CONFIRMED WITH THIS ANGIO ON (B)(6) 2023. THE PHYSICIAN NOTIFIED THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT HAD PASSED AWAY DURING THE NIGHT OF (B)(6) 2023 TO (B)(

  Patient problems: Insufficient Information

  MAUDE report 16482241 ↗
• MalfunctionOct 8, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  2021-OCT-04 MW5104101 (OTH): MEDTRONIC RECEIVED INFORMATION THAT A PHENOM CATHETER TIP HAD SHEARED OFF AND A SECOND MARKER TIP WAS NOTICED ON A QAPEL WAHOO CATHETER. IT WAS REPORTED THAT SUBOPTIMAL APPOSITION OF THE STENT AT THE DISTAL END AND INTRODUCED A TRANSFORM 7X7MM BALLOON ALONG WITH THE TRAXCESS MICROWIRE. DURING THE INTRODUCTION OF THE MICROCATHETER, IT WAS NOTICED THERE WAS A SECOND RADIO-OPAQUE MARKER AT THE TIP OF THE WAHOO JUST AS THE MICROWIRE WAS ABOUT TO REACH THE END OF THE WAHOO TIP. HOWEVER, BY THEN, IT WAS TOO LATE AS THE MICROWIRE GENTLY TOUCHED THE RADIO-OPAQUE MARKER AND IT TRAVELLED DISTALLY INTO THE LEFT DISTAL PCA. IT WAS AT THIS TIME THAT THE PHENOM PLUS CATHETER WAS CHECKED AND NOTED THAT THE TIP WAS SHEARED OFF. HOWEVER, GIVEN THE DISTAL LOCATION OF THE CURRENT MARKER TIP LOCATION, AND IT DOES NOT APPEAR TO BE OCCLUSIVE. REPEAT ANGIOGRAM DID NOT SHOW THROMBOSIS. WE FELT THAT IT WOULD BE SAFER TO LEAVE IT AS IT IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599164 ↗
• MalfunctionAug 9, 2021Break; Difficult to Remove; Physical Resistance/Sticking; Break; Difficult to Remove; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM PLUS CATHETER EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE GUIDE CATHETER AND SEPARATED. THE PATIENT WAS UNDERGOING ONYX EMBOLIZATION TREATMENT IN THE MIDDLE MENINGEAL ARTERY. THE VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE THE FEMORAL ARTERY, WHICH WAS 5MM IN DIAMETER. IT WAS REPORTED THAT THE PHENOM PLUS CATHETER WOULD NOT TRAVEL THROUGH THE BENCHMARK GUIDE CATHETER, AND THE DISTAL END OF THE PHENOM CATHETER RIPPED AND BECAME DETACHED. THE GUIDE CATHETER APPEARED VERY FLATTENED, WHICH WAS THOUGHT TO BE THE REASON FOR THE DETACHMENT. IT WAS NOTED THAT THE THERE WAS FRICTION/DIFFICULTY DURING INJECTION, AND FORCE HAD BEEN APPLIED DURING DELIVERY/REMOVAL. THE CATHETER TIP WAS ENTRAPPED/STUCK, AND THERE WAS NO VASOSPASM. NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PENUMBRA BENCHMARK .071 GUIDE CATHETER AND AN APOLLO MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294521 ↗