CLASS I Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Shuttle Select Slip-Cath Catheter recalled by Cook

Cook is recalling Shuttle Select Slip-Cath Catheter, distributed nationwide in the US. The recall was initiated on 7 Oct 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll 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

Quantity recalled9519

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0798-2016
FDA event ID: 72387
Recalling firm: Cook, Bloomington, IN
Classification: Class I
Status: Terminated
Recall initiated: 7 Oct 2015
FDA classified: 24 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

7 Oct 2015	Recall initiated by company
24 Feb 2016	Classified by FDA	+140 days
2 Mar 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Is Shuttle Select Slip-Cath Catheter recalled?

Yes. Cook recalled Shuttle Select Slip-Cath Catheter on 7 Oct 2015. The recall is Class I and its status is Terminated. Recall number Z-0798-2016.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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