FDA Device recall Z-2614-2016

Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicia…

FDA Device
Class II
terminated
Published 2016-08-31

On 2016-08-31 the FDA classified a Class II recall of Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicia… 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-2614-2016
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

Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

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 SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-10… All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G1199

code_info

All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-10…

All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G1199

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-2614-2016%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.