# FDA recall Z-1024-2019

> **Cook Medical Incorporated** · Class III · device recall initiated 2019-02-25.

## Product

Cook Celect Platinum Vena Cava Filter Set  for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT    Product Usage:  The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

## Reason for recall

Updates to the Instructions for Use.

## Distribution

The products were distributed US Nationwide Distribution

## Key facts

- **Recall number:** Z-1024-2019
- **Recalling firm:** Cook Medical Incorporated
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-25
- **Report date:** 2019-03-27
- **Termination date:** 2020-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2019

## Citation

> AI Analytics. FDA recall Z-1024-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1024-2019. Source: US FDA. Licensed CC0.

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