Cook Inc.: Medical Device Recall in 2016 - (Recall #: Z-2612-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 15, 2016

Date Posted: August 31, 2016

Recall Number: Z-2612-2016

Event ID: 74010

Reason for Recall:

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.

Status: Terminated

Product Quantity: 332,255

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated