—#145892

Product

Beacon Tip Royal Flush Plus High-Flow 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 HNR5.0 Catalog/product number; Global/order number HNR5.0-35-100-P-10S-0 G09697 HNR5.0-35-100-P-10S-CFP G11264 HNR5.0-35-100-P-10S-PIG G09059 HNR5.0-35-100-P-8S-VCF G31403 HNR5.0-35-100-P-NS-0 G10313 HNR5.0-35-100-ST-10S-0 G09565 HNR5.0-35-100-ST-10S-PIG G09525 HNR5.0-35-110-P-10S-0 G11241 HNR5.0-35-110-P-10S-PIG G11265 HNR5.0-35-65-P-8S-VCF G12129 HNR5.0-35-70-P-10S-0 G09411 HNR5.0-35-70-P-10S-CFP G11262 HNR5.0-35-70-P-10S-PIG G08832 HNR5.0-35-70-P-10S-PIG-RICKETTS-081983 G11280 HNR5.0-35-70-P-4S-PED G11281 HNR5.0-35-70-P-NS-0 G11959 HNR5.0-35-70-ST-10S-0 G09564 HNR5.0-35-70-ST-10S-PIG G09050 HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860 HNR5.0-35-90-P-10S-0 G09412 HNR5.0-35-90-P-10S-CFP G11266 HNR5.0-35-90-P-10S-PIG G09408 HNR5.0-35-90-P-10S-PIG-RICKETTS-081983 G11282 HNR5.0-35-90-P-6S-PED G11729 HNR5.0-35-90-P-8S-VCF G12799 HNR5.0-35-90-ST-10S-0 G11641 HNR5.0-35-90-ST-10S-PIG G09197 HNR5.0-38-100-P-10S-0 G11267 HNR5.0-38-100-P-10S-CFP G11268 HNR5.0-38-100-P-10S-PIG G09285 HNR5.0-38-100-P-NS-0 G27874 HNR5.0-38-110-P-10S-0 G09461 HNR5.0-38-110-P-10S-PIG G11269 HNR5.0-38-70-P-10S-0 G11270 HNR5.0-38-70-P-10S-CFP G11271 HNR5.0-38-70-P-10S-PIG G11272 HNR5.0-38-70-P-NS-0 G11289 HNR5.0-38-80-P-10S-OPC G27877 HNR5.0-38-90-P-10S-0 G11273 HNR5.0-38-90-P-10S-CFP G11274 HNR5.0-38-90-P-10S-PIG G11275

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 #145892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.