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

FDA device recall Z-0798-2016 · posted 2016-02-24 · Terminated

Recall details

Recalling firm

Cook Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

DQO

Quantity affected

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 Dar

Date initiated

2015-10-07

Date posted

2016-02-24

Date terminated

2017-09-02

Location

Bloomington, IN

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