Home / Brands / Cook Medical Incorporated
Cook Medical Incorporated Recalls
53 recalls on record · November 5, 2014 to October 22, 2025 · Medical Devices
Recalls by year
14
16
17
18
19
22
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary S
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
August 16, 2017Medical DevicesFDA
Cook Medical Incorporated recalls Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascu
Hazard: There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.
February 3, 2016Medical DevicesFDA
Cook Medical Incorporated recalls Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Hazard: Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event
November 5, 2014Medical DevicesFDA
Cook Medical Incorporated recalls Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that
Hazard: MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.