Flexor G56278Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002562783), received between May 7, 2018 and May 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0993-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionMay 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE VALVE PORTION OF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH LEAKED AS THE CATHETER WAS BEING INTRODUCED. AFTER REPLACING THE SHEATH, THE BALLOON WAS SUCCESSFULLY INTRODUCED. NO INFORMATION WAS PROVIDED REGARDING MANUFACTURER OF THE CATHETER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND COMPLAINT DEVICE RETURN HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7491670 ↗