FDA Device recall Z-2610-2016

Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

FDA Device
Class II
terminated
Published 2016-08-31

On 2016-08-31 the FDA classified a Class II recall of Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic by Cook, citing 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 dev….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2610-2016
Classification	Class II
Status	terminated
Initiated	2016-04-15
Published	2016-08-31
Last updated	2026-09-13 11:54 UTC
Company	Cook
Distribution	US

Product

Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

Reason

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.

Identifiers

code_info	All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G… All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G09916 HNBR5.0-35-100-P-NS-C1 G08623 HNBR5.0-35-100-P-NS-C2 G08796 HNBR5.0-35-100-P-NS-CANADA-041480 G12570 HNBR5.0-35-100-P-NS-DAV G08699 HNBR5.0-35-100-P-NS-FC3 G11204 HNBR5.0-35-100-P-NS-H1 G08421 HNBR5.0-35-100-P-NS-H3 G08918 HNBR5.0-35-100-P-NS-HN1 G09741 HNBR5.0-35-100-P-NS-HN4 G08917 HNBR5.0-35-100-P-NS-HNK1 G27811 HNBR5.0-35-100-P-NS-JB1 G08472 HNBR5.0-35-100-P-NS-JB2 G08809 HNBR5.0-35-100-P-NS-JB3 G08577 HNBR5.0-35-100-P-NS-MAN G08511 HNBR5.0-35-100-P-NS-MIK G11652 HNBR5.0-35-100-P-NS-MPA G11468 HNBR5.0-35-100-P-NS-SIM1 G08471 HNBR5.0-35-100-P-NS-SIM2 G08422 HNBR5.0-35-100-P-NS-SIM3 G08597 HNBR5.0-35-100-P-NS-VERT G11483 HNBR5.0-35-100-P-NS-WAIKATO G13803 HNBR5.0-35-100-P-NS-WNBG G08805 HNBR5.0-35-125-P-NS-C2 G12899 HNBR5.0-35-125-P-NS-C-PS G31970 HNBR5.0-35-125-P-NS-DAV G11375 HNBR5.0-35-125-P-NS-H1 G13258 HNBR5.0-35-125-P-NS-SIM2 G1

code_info

All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G…

All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G09916 HNBR5.0-35-100-P-NS-C1 G08623 HNBR5.0-35-100-P-NS-C2 G08796 HNBR5.0-35-100-P-NS-CANADA-041480 G12570 HNBR5.0-35-100-P-NS-DAV G08699 HNBR5.0-35-100-P-NS-FC3 G11204 HNBR5.0-35-100-P-NS-H1 G08421 HNBR5.0-35-100-P-NS-H3 G08918 HNBR5.0-35-100-P-NS-HN1 G09741 HNBR5.0-35-100-P-NS-HN4 G08917 HNBR5.0-35-100-P-NS-HNK1 G27811 HNBR5.0-35-100-P-NS-JB1 G08472 HNBR5.0-35-100-P-NS-JB2 G08809 HNBR5.0-35-100-P-NS-JB3 G08577 HNBR5.0-35-100-P-NS-MAN G08511 HNBR5.0-35-100-P-NS-MIK G11652 HNBR5.0-35-100-P-NS-MPA G11468 HNBR5.0-35-100-P-NS-SIM1 G08471 HNBR5.0-35-100-P-NS-SIM2 G08422 HNBR5.0-35-100-P-NS-SIM3 G08597 HNBR5.0-35-100-P-NS-VERT G11483 HNBR5.0-35-100-P-NS-WAIKATO G13803 HNBR5.0-35-100-P-NS-WNBG G08805 HNBR5.0-35-125-P-NS-C2 G12899 HNBR5.0-35-125-P-NS-C-PS G31970 HNBR5.0-35-125-P-NS-DAV G11375 HNBR5.0-35-125-P-NS-H1 G13258 HNBR5.0-35-125-P-NS-SIM2 G1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2610-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.