PhenomTM 21 Catheter FG13150-0615-2S (UDI 00847536041813)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536041813), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2021Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DELIVERY SYSTEM AND PIPELINE VANTAGE WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND DELIVERED TO THE TARGET LOCATION SMOOTHLY WITH NO ISSUES. THE STENT WAS DEPLOYED WITH NO ISSUES, AND THE STENT OPENED WELL. THE PROXIMAL END REQUIRED SLIGHT WAGGING TO FULLY APPOSE. THE PHYSICIAN DID NOT WANT TO TAKE THE CATHETER FULLY THROUGH TO CAPTURE THE SLEEVES, AND THE RHV HAD NOT BEEN LOCKED DOWN. WHEN INJECTING THE CONTRAST FOR A RUN, THE MICROCATHETER MOVED FORWARD THROUGH THE CENTER OF THE BRAID INDEPENDENTLY, AND WAS BEYOND THE DISTAL END OF THE BRAID. WHEN TRYING TO PULL THE DELIVERY WIRE AND SLEEVES TO RECAPTURE, IT WAS NOTED TO BE DIFFICULT AND THERE WAS RESISTANCE. THE CATHETER AND WIRE WERE SUCCESSFULLY REMOVED CAREFULLY. ONCE REMOVED, IT WAS NOTICED THE PHENOM HAD ACCORDIONED, AND IT WAS DIFFICULT TO PULL THE WIRE BACK THROUGH. IT WAS NOTED THE PATIENT HAD BRADYCARDIA DURING DEPLOYMENT OF TWO OCCASIONS WHICH RESOLVED ON DRAWING BACK THE CAT 5 NO FURTHER ISSUES. THERE WAS NO OTHER INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING

  Patient problems: Bradycardia

  MAUDE report 12393912 ↗