Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0875-2022·Announced 2022-04-13

Vena Cava Filter Sets Recalled for Instruction for Use Documentation Updates

Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III classification with no reported illnesses or injuries. The recall involves updates to Instruction for Use labeling and documentation including device description, indications, contraindications, warnings, and precautions, which constitute labeling/documentation issues without reported adverse events.

Plain-English summary

Cook Medical Incorporated recalled Gunther Tulip Vena Cava Filter Sets for Femoral Vein Approach due to updates required in the Instruction for Use (IFU) documentation. The necessary updates covered the device description, intended use/indications, contraindications, warnings, precautions, and information on potential adverse events.

The recall affected approximately 24,641 units distributed nationwide in the United States and internationally to Canada, Bahamas, Chile, and Guam. Affected products were manufactured between January 24, 2019 and January 24, 2022, with expiration dates ranging from January 8, 2022 through January 18, 2025.

Healthcare providers should refer to the updated Instruction for Use documentation for these devices. No illnesses or injuries were reported in connection with this recall. The FDA classified this recall as Class III.

The recalled product

Product: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Manufacturer: Cook Medical Incorporated
Category: Medical Device — Vascular / Cardiovascular
Hazard: documentation-error
mis-labeling
Affected units: 24,641

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Cook Medical Incorporated

See all →

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