PhenomTM 27 Catheter FG15150-0630-1S (UDI 00847536041875)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536041875), received between Dec 3, 2019 and Dec 20, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  2022-OCT-24 MPXR 996323 (REP, HCP, FOR, DIS): MEDTRONIC RECEIVED REPORT THAT THE PIPELINE JAMMED IN THE HUB OF THE PHENOM 27 MICROCATHETER. IT WAS NOTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE CATHETER HUB. THE CATHETER WAS FLUSHED PER IFU. BOTH DEVICES WERE REPLACED WITH ANOTHER MANUFACTURER'S PRODUCTS TO COMPLETE THE PROCEDURE. THERE WAS NO NOTED PATIENT INVOLVEMENT. 2022-11-08 E1 (FOR, REP, HCP): NEW INFORMATION WAS RECEIVED. THERE WAS NO DAMAGE OBSERVED ON THE PIPELINE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015412 ↗
• MalfunctionNov 16, 2021No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION AND WAS DAMAGED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 7MM, AND THE NECK DIAMETER WAS 6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4MM DISTAL AND 4.5MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS IN PLACE AND THE DOCTOR STARTED TO DELIVER THE PIPELINE IT WAS FOUND THAT THE STENT WAS KINKED AT THE HORIZONTAL SECTION OF C4, AND THE ANTERIOR AND POSTERIOR SITES COULD BE OPENED. THE KINK AND FLATTENED HORIZONTAL SECTION OF THE STENT COULD NOT BE RESOLVED BY PUSHING AND PULLING THE STENT SEVERAL TIMES. THE PIPELINE WAS REPEATEDLY RETRIEVED AND REPOSITIONED TO THE DISTAL SIDE. AFTER MORE THAN TWO RESHEATHING ATTEMPTS, IT WAS STILL KINKED AT THE C4 HORIZONTAL SEGMENT AND COULD NOT BE DEPLOYED NORMALLY. IT WAS NOTED THAT THERE WERE BURRS ON THE TIP OF THE PIPELINE, SO THE ENTIRE PIPELINE AND MICROCATHETER DELIVERY SYSTEM WERE WITHDRAWN. THE PIPELINE WAS NOT POSITIONED IN A BEND WHEN THE MIDDLE SECTION FAILED TO OPEN, AND MOR

  Patient problems: Insufficient Information

  MAUDE report 12820146 ↗
• MalfunctionNov 4, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE AND TWISTING DURING DELIVERY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE SUPERCLINOID ICA. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). SEVERE TORTUOSITY WAS MET WHILE ADVANCING THE PIPELINE, AND DIFFICULTY WAS MET. THE PIPELINE TWISTED DISTALLY DESPITE RE-SHEATHING, AND ALSO TWISTED PROXIMALLY DESPITE RE-SHEATHING DISTAL TO TWIST. THE PHYSICIAN ATTEMPTED TO RE-POSITION AND REDEPLOY THE PIPELINE, BUT TWISTING CONTINUED TO OCCUR. THE PIPELINE AND PHENOM MICROCATHETER WERE THEN REMOVED. A NEW MICROCATHETER AND DEVICE WERE THEN USED WITH SUCCESS. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED A SUCCESSFUL PROCEDURE. ANCILLARY DEVICES INCLUDE A NEURON MAX, PHENOM PLUS, PHENOM 27, FATHOM 16. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS THROUGHOUT THE CATHETER, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE OR CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10786271 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEVELOPED A FISTULA DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR AN UNRUPTURED AMORPHOUS ANEURYSM LOCATED IN RIGHT INTERNAL CAROTID ARTERY (ICA) LANDING ZONE DISTAL 3.2MM PROXIMAL 4.7MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PHYSICIAN ADVANCED A GUIDE CATHETER AND MICROCATHETER. A RUN WITH CONTRAST REVEALED A FISTULA THAT THE PHYSICIAN BELIEVES WAS CATHETER INDUCED. THE PHYSICIAN DECIDED TO ¿SACK¿ THE VESSEL AS THE RIGHT ICA ON IMAGING WAS BEING WELL FED FROM CONTRALATERAL FLOW. RIGHT ICA WAS SACRIFICED; THE PATIENT¿S CONTRALATERAL FLOW WAS FEEDING RIGHT CIRCULATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: Fistula

  MAUDE report 9407275 ↗