Device recall: Amplatz Extra Stiff Whisker Wire Guide

FDA enforcement event 79195 · Class II · initiated 13 Oct 2017 · status Terminated · terminated 23 Oct 2019

DeviceVoluntary: Firm initiated20 product recordsBloomington, IN

Cook Inc. (Bloomington, IN) initiated this device recall on 13 Oct 2017; FDA lists 20 product records under event 79195, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 23 Oct 2019. Initiation: voluntary: firm initiated. Cook Inc. has 61 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Cook Inc., Bloomington, IN.

Reason for recall

"Label does not state that the product is heparin-coated."

Distribution

"Nationally"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0947-2018	Amplatz Extra Stiff Whisker Wire Guide	648	Class II	Terminated	21 Mar 2018
Z-0948-2018	Amplatz Extra Stiff Wire Guide	129,727	Class II	Terminated	21 Mar 2018
Z-0949-2018	Amplatz Stiff Wire Guide	32,340	Class II	Terminated	21 Mar 2018
Z-0950-2018	Amplatz Ultra Stiff Wire Guide	12,462	Class II	Terminated	21 Mar 2018
Z-0951-2018	Bentson Cerebral Wire Guide	45	Class II	Terminated	21 Mar 2018
Z-0952-2018	Bentson Plus Wire Guide	8,147	Class II	Terminated	21 Mar 2018
Z-0953-2018	Bentson Wire Guide	439,797	Class II	Terminated	21 Mar 2018
Z-0954-2018	Coons Interventional Wire Guide	3,369	Class II	Terminated	21 Mar 2018
Z-0955-2018	Disposable Reuter Tip Deflecting Wire Guide	18,398	Class II	Terminated	21 Mar 2018
Z-0956-2018	Double Flexible Tipped Wire Guide	10,367	Class II	Terminated	21 Mar 2018
Z-0957-2018	Fixed Core Bentson	2,210	Class II	Terminated	21 Mar 2018
Z-0958-2018	Fixed Core Wire Guide	601,778	Class II	Terminated	21 Mar 2018
Z-0959-2018	Movable Core Wire Guide	21,913	Class II	Terminated	21 Mar 2018
Z-0960-2018	Newton Wire Guide	41,113	Class II	Terminated	21 Mar 2018
Z-0961-2018	Reuter Tip Deflecting Wire Guide	55	Class II	Terminated	21 Mar 2018
Z-0962-2018	Rosen Curved Wire Guide	98,502	Class II	Terminated	21 Mar 2018
Z-0963-2018	TFE Coated Curved Newton LLT	3,364	Class II	Terminated	21 Mar 2018
Z-0964-2018	Central Venous Catheter Tray	13	Class II	Terminated	21 Mar 2018
Z-0965-2018	Left Atrial Catheter Set	56	Class II	Terminated	21 Mar 2018
Z-0966-2018	Femoral Artery Pressure Monitoring Set	266	Class II	Terminated	21 Mar 2018

Context

93%of 2017 device events are Class II1,091 events that year

20product records in this eventfirm median: 2

61events on this register for the firm

Other enforcement events for Cook Inc.

Initiated	Product (first record)	Type	Class	Records
12 Nov 2021	Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Inten	Device	Class II	2
13 Oct 2021	Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide	Device	Class II	1
8 Oct 2021	Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle	Device	Class II	2
28 Sep 2021	Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydr	Device	Class II	2
4 Jan 2021	Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal S	Device	Class II	1
24 Nov 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths	Device	Class I	21
22 Oct 2020	Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured	Device	Class I	1
31 Aug 2020	Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22	Device	Class II	2
11 Aug 2020	Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients w	Device	Class II	1
30 Jul 2020	Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for tempo	Device	Class II	1

All 61 events for Cook Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Label does not state that the product is heparin-coated."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationally"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 23 Oct 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.