Z-0798-2016Class I

Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for...

Name: Z-0798-2016 Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for...
Creator: Cook Inc.
Published: 2015-10-07
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2015-10-07 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help... on 2015-10-07. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0798-2016
Classification: Class I
Status: Terminated
Initiated: 2015-10-07
Posted: 2016-02-24
Terminated: 2017-09-02
Recalling firm: Cook Incorporated
Product: Shuttle Select Slip-Cath 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.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: 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. Recall expanded 10/07/2015 to include additional catheters.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 7/2/2015 Cook Incorporated sent, URGENT: MEDICAL DEVICE RECALL notifications dated July 2, 2015, to affected customers with instructions for returning the affected product. All customers were notified via courier. 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. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.On 10/09/2015 the firm expanded the recall and reissued press release via www.businesswire.com to include additional catheter products and lots as specified in the release.
Quantity in commerce: 9519
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.
Product codes and lots: All lot numbers of the following Product numbers: SCBR4.5-35-135-P-NS-ANG-SHTL, SCBR4.5-35-135-P-NS-ANG-SHTL-JP, SCBR4.5-35-150-P-NS-0-SHTL, SCBR4.5-35-150-P-NS-ANG-SHTL, SCBR4.5-35-75-P-NS-ANGSHTL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0798-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0798-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code DQO

K122937Class IISlip-Cath Beacon Tip Catheter Model Scbr (Product Prefix), Shuttle Select Slip-Cath Catheter Model Scbr (Product Prefix)Cook, Inc. / cleared 2012-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)