Flexor G13033Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002130333), received between May 12, 2017 and Sep 17, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Break1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Fluid/Blood Leak1
- Material Protrusion/Extrusion1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
UPON RETURN OF THE DEVICE ON 30SEP2024, THE SHEATH WAS SEPARATED INTO TWO SECTIONS, AND THE PROXIMAL END OF THE SHEATH PROTRUDED FROM THE HUB.
Patient problems: Insufficient Information
MAUDE report 20238788 ↗MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11406381 ↗MalfunctionMay 12, 2017Difficult to Remove; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA (IVC) FILTER REMOVAL CASE, IT WAS QUITE DIFFICULT TO WITHDRAW THE FILTER WITHIN THE SHEATH. THE SCRUB NURSE HOLDING THE SHEATH SAID THAT IT FELT LIKE SOMETHING WAS DRAGGING. THE FILTER AND 15 MM SNARE RETRIEVAL SYSTEM ALL CAME OUT, BUT WHEN THE SHEATH WAS REMOVED, AND THE DOCTOR WAS HOLDING PRESSURE, THERE WAS A WHITE STRING/FIBRE STICKING OUT THE ACCESS SITE. THIS WAS REMOVED AND THE PATIENT WAS STABLE. AFTER ACHIEVING HEMOSTASIS, THE PATIENT WAS SENT TO DAY SURGERY FOR POST PROCEDURE CARE, PRIOR TO BEING DISCHARGED THAT AFTERNOON. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6563311 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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