Check-Flo G08686Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002086869), received between Feb 25, 2015 and Mar 13, 2025 — classified as 2 malfunctions.

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. Apr 17, 2025Open, Classified

   Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

   Z-1786-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025

  THE PACKAGE IS LABELED AS A COOK 10F X30CM SHEATH. THE SCRUBBER NOTICED THAT THE ACTUAL SHEATH IS LABELED AS A 14F SHEATH. THIS DID NOT TOUCH THE PATIENT. THE SCRUBBER NOTICED IT AS HE WAS SETTING UP THE TABLE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592650 ↗
• MalfunctionFeb 25, 2015Fluid/Blood Leak

  WHEN PERFORMING A TIPSS PROCEDURE (TRANSJUGULAR INTRAHEPATIC PORTO-SYSTEMIC SHUNT), AFTER THE INTRODUCER WAS PLACED IN THE PT, THE PHYSICIAN REALIZED THAT THE CONNECTION (HUB) WAS NOT WELL ATTACHED AFTER NOTICING BLOOD LEAKING THROUGH THE JUNCTION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4576399 ↗