ENVOY 556-256-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704027935), received between Aug 20, 2020 and Oct 13, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 16, 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.

• MalfunctionOct 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, DURING A CEREBRAL ANGIOGRAPHY, ASPIRATION AIR CAME IN AND DURING INJECTION WATER CAME OUT AT THE BEGINNING OF ON AN ENVOY 5F, MPC 100 CM CATHETER (55625600, 30247204). THERE WAS A PROCEDURAL DELAY OF FIVE MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION CLARIFIED THAT THE ASPIRATION WAS ¿RIGHT¿, THE CATHETER SUCK AIR BETWEEN THE HUB. THE DEVICE DID NOT APPEAR KINKED, COMPRESSED, CRACKED OR HAD ANY OTHER DAMAGE. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE TARGET VESSEL/SITE WAS THE RIGHT VERTEBRAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670940 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FILED, DURING A CEREBRAL ANGIOGRAPHY, ASPIRATION AIR CAME IN AND DURING INJECTION WATER CAME OUT AT THE BEGINNING OF ON AN ENVOY 5F, MPC 100 CM CATHETER (55625600, 30247204). THERE WAS A PROCEDURAL DELAY OF FIVE MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION CLARIFIED THAT THE ASPIRATION WAS ¿RIGHT¿, THE CATHETER SUCK AIR BETWEEN THE HUB. THE DEVICE DID NOT APPEAR KINKED, COMPRESSED, CRACKED OR HAD ANY OTHER DAMAGE. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE TARGET VESSEL WAS THE RIGHT CAROTID.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431087 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FILED, DURING A CEREBRAL ANGIOGRAPHY, ASPIRATION AIR CAME IN AND DURING INJECTION WATER CAME OUT AT THE BEGINNING OF ON AN ENVOY 5F, MPC 100 CM CATHETER (55625600, 30289560). THERE WAS A PROCEDURAL DELAY OF FIVE MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION CLARIFIED THAT THE ASPIRATION WAS ¿RIGHT¿, THE CATHETER SUCK AIR BETWEEN THE HUB. THE DEVICE DID NOT APPEAR KINKED, COMPRESSED, CRACKED OR HAD ANY OTHER DAMAGE. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE TARGET VESSEL/SITE WAS THE RIGHT VERTEBRATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10430936 ↗