Performer recallZ-1787-2025 · Cook Incorporated · initiated Apr 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
FDA root cause category: Under Investigation by firm
What the company is doing
Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 04/17/2025 via FedEx Standard Overnight. The notice explained the issue, potential risk to health and requested: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected].
Recall details
- Recall number
- Z-1787-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 17, 2025
- Posted by the FDA
- May 16, 2025
- Recalling firm
- Cook Incorporated
- Quantity
- 89 units
- Product code
- DYB
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Product description
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Code information (models, lots, serial numbers)
UDI/DI 00827002089570, Lot Number 16376242
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Performer G08957Cook Incorporated · INTRODUCER, CATHETER1 recall3 deaths41 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96703).
- Z-1786-2025 · Open, ClassifiedCheck=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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