FDA Device recall Z-0798-2016
Shuttle Select Slip-Cath Catheter
- FDA Device
- Class I
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class I recall of Shuttle Select Slip-Cath Catheter by Cook, citing reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occlud….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0798-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-10-07 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | US |
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.
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. Recall expanded 10/07/2015 to include additional catheters.
Identifiers
| code_info | 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, S…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0798-2016%22
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