Cook Inc.: Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

Recall number

Z-2613-2016

Recalling firm

Cook Inc.

Product

Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

Status

Terminated

Initiated

2016-04-15

Posted

2016-08-22

Terminated

2017-08-04

Reason

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Root cause

Unknown/Undetermined by firm

Action

Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, 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. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.

Quantity

60,302

Distribution

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

Lot, serial or model codes

All Lots. Catalog prefixes/suffixes SCBR5.5-/-SHTL SCBR6.5-/-SHTL  Catalog/product number; Global/order number SCBR5.5-35-125-P-NS-H1-SHTL G31129 SCBR5.5-35-125-P-NS-JB1-SHTL G31130 SCBR5.5-35-125-P-NS-JB2-SHTL G36361 SCBR5.5-35-125-P-NS-MPA-SHTL G23697 SCBR5.5-35-125-P-NS-SIM1-SHTL G23699 SCBR5.5-35-125-P-NS-SIM2-SHTL G36360 SCBR5.5-35-125-P-NS-VERT-SHTL G23698 SCBR5.5-35-125-P-NS-VTK-SHTL G36359 SCBR5.5-35-135-P-NS-ANG-SHTL G48154 SCBR5.5-35-150-P-NS-0-SHTL G23705 SCBR5.5-35-150-P-NS-ANG-SHTL G23704 SCBR5.5-35-75-P-NS-ANG-SHTL G48152 SCBR6.5-35-125-P-NS-H1-SHTL G31134 SCBR6.5-35-125-P-NS-JB1-SHTL G31135 SCBR6.5-35-125-P-NS-JB2-SHTL G36364 SCBR6.5-35-125-P-NS-SIM1-SHTL G23701 SCBR6.5-35-125-P-NS-SIM2-SHTL G36363 SCBR6.5-35-125-P-NS-VERT-SHTL G23700 SCBR6.5-35-125-P-NS-VTK-SHTL G36362

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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