PhenomTM 27 Catheter FG15150-0630-1S (UDI 00763000399719)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000399719), received between Aug 11, 2022 and Apr 27, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE OCCURRED WHEN ADVANCING THE DISTAL TIP OF THE PHENOM IN THE GUIDE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS QUITE SEVERE WHICH CONTRIBUTED TO THE DEPLOYMENT DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009017 ↗
• MalfunctionJan 23, 2026Retraction Problem

  NO NEW INFORMATION RECEIVED AND ALL THE INFORMATION HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168457 ↗
• MalfunctionOct 31, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2), ABOUT HALFWAY THROUGH THE RELEASE, THE DEVICE DID NOT PROPERLY CONFORM TO THE ARTERY, FAILING TO REACH EVEN THE DISTAL DIAMETER OF 3.6 MM, AND IN THE MID PORTION IT BARELY OPENED. ALL OF THE RECOMMENDED MANEUVERS WERE PERFORMED, BUT WITHOUT SUCCESS. AFTER SEVERAL ATTEMPTS, IT WAS DECIDED TO REPLACE THE DEVICE. WHILE ATTEMPTING TO REMOVE THE PIPELINE FROM THE PHENOM 27 MICROCATHETER OUTSIDE THE PATIENT, THERE WAS RESISTANCE, AND THE WIRE EVENTUALLY BROKE. THE STENT AND MICROCATHETER WERE REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.1 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.6 MM DISTALLY AND 4.1 MM PROXIMALLY. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23440200 ↗
• MalfunctionAug 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER. THE PIPELINE WAS SUCCESSFULLY DELIVERED AND DEPLOYED AT THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829141 ↗
• MalfunctionJul 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LOT NUMBER OF THE PHENOM WAS 229935367.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420679 ↗
• MalfunctionAug 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END WAS NOT OPENING AS NEEDED. DEVICE WAS RECAPTURED TWICE. DISTAL END OF DEVICE APPEARED TO BE FRAYED ONCE THEY GOT THE DEVICE TO OPEN. THEY REMOVED DEVICE AND DEPLOYED A DIFFERENT PIPELINE, SAME SIZE, WITH SUCCESS. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY ANEURYSM. THE LANDING ZONE WAS 3.99MM D ISTALLY AND 5.9MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL PIPELINE SHIELD DEPLOYMENT. ANCILLARY DEVICES INCLUDE A BMX GUIDE CATHETER, PHENOM AND NAVIEN MICROCATHETERS, SYNCHRO 14S GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED TWICE, LOAD WAS PUT ON DEVICE AND UNLOAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050526 ↗
• InjuryMar 1, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT WHILE ATTEMPTING TO DELIVER A PED2-250-10 IN VERY TORTUOUS ANATOMY, THE PHENOM 27 BROKE IN THE MIDDLE SECTION. THE PHYSICIAN RECOGNIZED IT IMMEDIATELY AND WAS ABLE TO REMOVE THE CATHETER WITH THE PIPELINE STILL INSIDE IT; THE CASE WAS STOPPED. CATHETER SEPARATION/BREAK OCCURRED DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES 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 OF A PSEUDOANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE LEFT A2 WITH 1MM DIAMETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459801 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE SHIELD STENTS THAT FAILED TO OPEN AND THE PATIENT'S VESSEL WAS PERFORATED CAUSING FISTULA. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED AMORPHOUS LEFT INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH PRU LEVEL 80. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE RIST GUIDE CATHETER WAS PLACED INT HE PATIENT'S LEFT ICA AND THE PHENOM 27 MICROCATHETER WAS GUIDED TO THE ANEURYSM LOCATION WITH THE NON-MEDTRONIC GUIDEWIRE. THE PIPELINE WAS FLUSHED WITH HEPARINIZED SALINE IN THE INTRODUCER SHEATH AND THEN WAS DELIVERED AND DEPLOYED IN THE MIDDLE CEREBRAL ARTERY (MCA). THE PIPELINE 5X18 WAS UNSHEATH AND PUSHED WITH THE PUSHWIRE TO DELIVER THE PIPELINE ACROSS THE ANEURYSM. WHEN THE PIPELINE WAS LESS THAN 50% DEPLOYED, THE DISTAL END FAILED TO OPEN. THE PIPELINE STILL COULD NOT BE OPENED EVENT AFTER CENTERING THE MICROCATHETER AND RESHEATHING UP TO THE PTFE SLEEVES. THE SURGEON ATTEMPTED "WAGGIN

  Patient problems: Fistula; Perforation of Vessels

  MAUDE report 15213917 ↗