PhenomTM 27 Catheter FG15160-0615-1S (UDI 00847536041882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536041882), received between Nov 9, 2020 and Jan 18, 2023 — classified as 2 injuries, 5 malfunctions.

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

• MalfunctionJan 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD THAT FAILED TO OPEN AT THE DISTAL END AND HAD RESISTANCE WITH R ESHEATHING IN THE PHENOM 27 MICROCATHETER.  THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION. VESSEL TORTUOSITY WAS SEVERE.  IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT, WHEN THE PIPELINE WAS MORE THAN 50% DEPLOYED, THE PIPELINE DISTAL END FAILED TO OPEN. AFTER 2 ATTEMPTS OF RESHEATHING, THE PHYSICIAN OBSERVED FISH-MOUTH DEFORMATION AT THE DISTAL END OF THE BRAID AND THE MIDDLE SEGMENT WAS ALSO NOT OPENED AT THE BEND. RESHEATHING IN THE PHENOM 27 MICROCATHETER WAS THEN ATTEMPTED AGAIN BUT WAS NOT ABLE TO AND THE MIDDLE SECTION OF THE PIPELINE REMAINED UNOPENED. IT WAS NOTED THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINE. THE PHYSICIAN THEN REMOVED THE SYSTEM TOGETHER AND REPLACED BOTH DEVICES TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195560 ↗
• MalfunctionAug 25, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION AND THE MARKSMAN CATHETER BROKE. DEVICE HAS PROBLEMS IN THE DISTAL OPENING AND AFTER 1/3 OF THE OPENING (IN THE SIPHON) IT WOULD NOT OPEN TO ANCHOR THE VESSEL WALL IN THE PORTION, THE DOCTOR PRESENTED ALL THE MANEUVERS AND RECOMMENDATIONS OF THE MANUFACTURER, WITHOUT OPENING SUCCESSFUL. THE DOCTOR'S CHOICE AFTER THE ATTEMPTS WAS TO EXCHANGE THE STENT FOR ANOTHER MEASURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER BROKE DUE TO THE PIPELINE DIVISOR NOT OPENING. IT WAS NECESSARY TO USE A NEW DELIVERY SYSTEM TO TREAT THE PATIENT AFTER CHANGING THE STENT AND MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC SEGMENT. THE MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS 3.5MM AND THE PROXIMAL LANDING ZONE WAS 4.75MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. AFTER REPLACING THE DEVICE (PIPELINE AND MICROCATHETER), THE ANEURYSM WAS EXCLUDED FROM THE ARTERY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298764 ↗
• MalfunctionMar 7, 2022Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM WAS DAMAGED 15-20CM OF THE DISTAL END. THE CATHETER WAS PUNCTURED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT. THE PATIENT HAD SEVERE VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE: SYNCHRO WIRE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13677925 ↗
• InjuryJun 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE MARKER BAND COMING DISLODGED WAS NOT DETERMINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11922282 ↗
• InjuryJan 7, 2021Difficult to Advance; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED PATIENT CONDITION, AND MEDICAL OR SURGICAL INTERVENTION, AND/OR OUTCOME WOULD NOT BE REPORTED DUE TO CONFIDENTIALITY/PRIVACY REASONS. THERE WAS NO KINK OR DAMAGE OBSERVED TO THE PUSHWIRE OF THE SOLITAIRE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11137343 ↗
• MalfunctionDec 5, 2020Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE BECAME STUCK/LOCKED UP IN A PHENOM CATHETER THAT ACCORDIONED. A SECOND PIPELINE WAS TOO LONG AND RIBBONED IN THE TURN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 8MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING DEPLOYMENT AND RE-SHEATHING, THE PIPELINE (PLI-10) BECAME STUCK/LOCKED UP AT THE HUB OF THE PHENOM MICROCATHETER (PLI-30). THE CATHETER WAS CONTINUOUSLY FLUSHEDWITH HEPARINIZED SALINE, AND THE PHYSICIAN RELEASED THE LOAD, BUT THE ISSUE DID NOT RESOLVE. THE PHENOM MICROCATHETER WAS ACCORDIONED AT THE DISTAL SEGMENT, AND THERE WAS NO DAMAGE NOTED TO THE PUSHWIRE. A SECOND PIPELINE (PLI-20) WAS THEN USED WITH A NEW PHENOM MICROCATHETER, BUT THE PIPELINE WAS TOO LONG AND RIBBONED IN THE TURN. THERE WAS NO ALLEGED PRODUCT ISSUE WITH THE SECOND PIPELINE. A REPLACEMENT PIPELINE WAS USED TO THEN COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10954398 ↗
• MalfunctionNov 9, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM CATHETER WAS CAUGHT ON A STENT, AND ONCE IN THE LOCATION NEEDED, THE DISTAL TIP COMPLETELY CAME OFF. A SNARE WAS USED TO CAPTURE THE TIP. IT WAS NOTED THERE WAS NO FRICTION DURING INJECTION, NO FORCE APPLIED, THE CATHETER TIP WAS NO ENTRAPPED, NO VASOSPASM, NOT STUCK IN GUIDE CATHETER, AND NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR AN OFF-LABEL VENUS STENTING PROCEDURE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10813874 ↗