Cook Inc.: Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Recall number

Z-2319-2015

Recalling firm

Cook Inc.

Product

Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Status

Terminated

Initiated

2015-07-02

Posted

2015-08-05

Terminated

2017-09-02

Reason

Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

Root cause

Component design/selection

Action

Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.

Quantity

248167

Distribution

Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Lot, serial or model codes

All lots of the following  Product numbers: SCBR4.0-35-150-P-NS-0,  SCBR4.0-35-65-P-NS-RC2,  SCBR4.0-38-100-P-NS-0,  SCBR4.0-38-100-P-NS-C2,  SCBR4.0-38-100-P-NS-DAV, SCBR4.0-38-100-P-NS-H1,  SCBR4.0-38-100-P-NS-HN4,  SCBR4.0-38-100-P-NS-JB1,  SCBR4.0-38-100-P-NS-JB2, SCBR4.0-38-100-P-NS-KMP,  SCBR4.0-38-100-P-NS-MAN,  SCBR4.0-38-100-P-NS-MPA,  SCBR4.0-38-100-P-NS-MPB, SCBR4.0-38-100-P-NS-SIM1,  SCBR4.0-38-100-P-NS-SIM2,  SCBR4.0-38-100-P-NS-SIM3,  SCBR4.0-38-100-P-NS-VERT, SCBR4.0-38-125-P-NS-0,  SCBR4.0-38-125-P-NS-DAV,  SCBR4.0-38-125-P-NS-JB1,  SCBR4.0-38-125-P-NS-SIM1, SCBR4.0-38-125-P-NS-SIM2,  SCBR4.0-38-125-P-NS-TEGT,  SCBR4.0-38-125-P-NS-VERT,  SCBR4.0-38-125-P-NS-VTK, SCBR4.0-38-40-P-NS-KMP,  SCBR4.0-38-65-P-NS-0,  SCBR4.0-38-65-P-NS-C2,  SCBR4.0-38-65-P-NS-KMP,  SCBR4.0-38-65-P-NS-MPA, SCBR4.0-38-65-P-NS-RIM,  SCBR4.0-38-65-P-NS-TC,  SCBR4.0-38-65-P-NS-TC-BNK,  SCBR4.0-38-65-P-NS-VERT, SCBR4.0-38-80-P-NS-RH,  SCBR4.0-38-80-P-NS-VS,  SCBR4.0-38-80-P-NS-VS1,  SCBR4.0-38-80-P-NS-VS2,  SCBR4.0-38-80-P-NS-VS3, SCBR4.1-35-65-P-NS-C2,  SCBR4.1-35-75-P-NS-CHG2.5, SCBR5.0-35-90-P-NS-RUC

510(k) numbers

["K122937"]

PMA numbers

not on file

Product code

DQO

Firm FEI

1820334

Firm city

Bloomington

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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