—#138759

Product

Slip-Cath Beacon Tip 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.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K122937
Affected lot / code info: All lots of the following Product numbers: SCBR4.0-35-150-P-NS-0, SCBR4.0-35-65-P-NS-RC2, SCBR4.0-38-100-P-NS-0, SCBR4.0-38-100-P-NS-C2, SCBR4.0-38-100-P-NS-DAV, SCBR4.0-38-100-P-NS-H1, SCBR4.0-38-100-P-NS-HN4, SCBR4.0-38-100-P-NS-JB1, SCBR4.0-38-100-P-NS-JB2, SCBR4.0-38-100-P-NS-KMP, SCBR4.0-38-100-P-NS-MAN, SCBR4.0-38-100-P-NS-MPA, SCBR4.0-38-100-P-NS-MPB, SCBR4.0-38-100-P-NS-SIM1, SCBR4.0-38-100-P-NS-SIM2, SCBR4.0-38-100-P-NS-SIM3, SCBR4.0-38-100-P-NS-VERT, SCBR4.0-38-125-P-NS-0, SCBR4.0-38-125-P-NS-DAV, SCBR4.0-38-125-P-NS-JB1, SCBR4.0-38-125-P-NS-SIM1, SCBR4.0-38-125-P-NS-SIM2, SCBR4.0-38-125-P-NS-TEGT, SCBR4.0-38-125-P-NS-VERT, SCBR4.0-38-125-P-NS-VTK, SCBR4.0-38-40-P-NS-KMP, SCBR4.0-38-65-P-NS-0, SCBR4.0-38-65-P-NS-C2, SCBR4.0-38-65-P-NS-KMP, SCBR4.0-38-65-P-NS-MPA, SCBR4.0-38-65-P-NS-RIM, SCBR4.0-38-65-P-NS-TC, SCBR4.0-38-65-P-NS-TC-BNK, SCBR4.0-38-65-P-NS-VERT, SCBR4.0-38-80-P-NS-RH, SCBR4.0-38-80-P-NS-VS, SCBR4.0-38-80-P-NS-VS1, SCBR4.0-38-80-P-NS-VS2, SCBR4.0-38-80-P-NS-VS3, SCBR4.1-35-65-P-NS-C2, SCBR4.1-35-75-P-NS-CHG2.5, SCBR5.0-35-90-P-NS-RUC

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, 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 and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-07-02
Posted by FDA: 2015-08-05
Terminated: 2017-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138759. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.