—#145893

Product

Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: All Lots. Catalog prefixes NR5.0 Catalog/product number; Global/order number Centimeter Sizing: NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-70-P-10S-PIG-CSC-20 G31215 NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-100-P-10S-0-CSC-20 G31214 White Vessel Sizing: NR5.0-35-70-P-10S-PIG-WSC G31224 NR5.0-35-70-P-10S-CFP-WSC G31227 NR5.0-35-70-P-10S-0-WSC G31228 NR5.0-35-65-P-6S-VCF-WSC G31229 NR5.0-35-100-P-10S-PIG-WSC G31226 Vessel Sizing: NR5.0-35-90-P-10S-VCF-CAVA G31233 NR5.0-35-90-P-10S-PIG-CAVA G31231 NR5.0-35-70-P-10S-VCF-CAVA G31232 NR5.0-35-70-P-10S-PIG-CAVA G31230

Why it was recalled

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, 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. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

Timeline

Recall initiated: 2016-04-15
Posted by FDA: 2016-08-22
Terminated: 2017-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145893. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.