CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Amplatz Ultra Stiff Wire Guide recalled by Cook

Cook is recalling Amplatz Ultra Stiff Wire Guide, distributed nationwide in the US. The recall was initiated on 13 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894

Quantity recalled12,462

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0950-2018
FDA event ID: 79195
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2017
FDA classified: 9 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Oct 2017	Recall initiated by company
9 Mar 2018	Classified by FDA	+147 days
21 Mar 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Amplatz Ultra Stiff Wire Guide

Where it was distributed

Nationally

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894

Where was it sold?

Nationally

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

19 other products · FDA event 79195

This product is part of a recall event; the main page for the event is Coons Interventional Wire Guide recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018	CLASS II	Coons Interventional Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Movable Core Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Amplatz Extra Stiff Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Bentson Cerebral Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Femoral Artery Pressure Monitoring Set recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Reuter Tip Deflecting Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Amplatz Stiff Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Double Flexible Tipped Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Left Atrial Catheter Set recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Bentson Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Amplatz Extra Stiff Whisker Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Central Venous Catheter Tray recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Fixed Core Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Bentson Plus Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Disposable Reuter Tip Deflecting Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Fixed Core Bentson recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	TFE Coated Curved Newton LLT recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Rosen Curved Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Newton Wire Guide recalled by Cook	Cook	Device Malfunction	Nationwide

More recalls from Cook

All 349

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled	Cook	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook	Other	IN
15 Apr 2026Device	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook	Other	IN

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide