PhenomTM Plus Catheter FG19120-1030-1S (UDI 00847536041936)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536041936), received between Dec 5, 2020 and Jan 11, 2024 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM PLUS CATHETER WAS FOUND BROKEN OUT OF THE PACKAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON OPENED THE PACKAGE AND FOUND THAT THE CATHETER WAS DAMAGED. IT WAS REPORTED THE CATHETER RUPTURED IN THE PROXIMAL SECTION. IT WAS ALSO REPORTED THE CATHETER WAS FOUND BROKEN. ASIDE FROM THE RUPTURE THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18497708 ↗
• DeathOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES WITH ANY OF THE DEVICES USED, AND NO FURTHER INFORMATION ON THE PATIENT WOULD BE RELEASED.

  Patient problems: Insufficient Information

  MAUDE report 12593532 ↗
• MalfunctionDec 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THERE WAS RESISTANCE WHEN RETRIEVING A PHENOM 27 THROUGH A PHENOM PLUS. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. PRIOR TO THE EVENT, IT WAS REPORTED THE PIPELINE WAS DEPLOYED SUCCESSFULLY AND UPON PULLING THE PHENOM BACK, THE REPORTED EVENT OCCU RRED. THE PHENOM 27 AND PHENOM PLUS WERE PULLED BACK AS A UNIT AND SUCCESSFULLY REMOVED FROM THE PATIENT. UPON OBSERVATION, THEY SUSPECTED THAT THERE MAY HAVE BEEN SOME OBSTRUCTION IN THE HUB OF THE PHENOM PLUS. IT WAS NOTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE IFUS. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE VASCULATURE WAS MINIMAL IN TORTUOSITY. ACCESS WAS THROUGH THE FEMORAL ARTERY WITH DIAMETER OF 5MM. THERE WAS NOT ANY DAMAGE OBSERVED ON PHENOM 27. THERE WAS NOT ANY DAMAGE OBSERVED ON PHENOM PLUS, IT WAS SOMETHING IN HUB THOUGH. DON¿T KNOW IF IT¿S AN INNER LINER OR PART OF ANOTHER CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10954260 ↗