CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

C-Flex Double Pigtail Ureteral Stent Set recalled by Cook

Cook is recalling C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367, distributed nationwide in the US. The recall was initiated on 4 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNS7953136 NS8169661 NS8180857 NS8169662 NS8180858 NS8180859 NS8180860

Quantity recalled13388 total

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-0973-2020
FDA event ID: 82026
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Jan 2019
FDA classified: 4 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

4 Jan 2019	Recall initiated by company
4 Feb 2020	Classified by FDA	+396 days
12 Feb 2020	Published in enforcement report	+8 days

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

Reason for recall

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Product as listed by the FDA

C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367

Where it was distributed

Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Which lots are affected?

NS7953136 NS8169661 NS8180857 NS8169662 NS8180858 NS8180859 NS8180860

Where was it sold?

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 82026

This product is part of a recall event; the main page for the event is Universa Firm Ureteral Stent recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020	CLASS II	Universa Firm Ureteral Stent recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	PTFE Wire Guide, Guidewire, Global Product Number recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Angled Tip Ureteral Catheter Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Bander Ureteral Diversion Open-End Stent Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Urethral Dilation Balloon Catheter with Open Tip recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Percutaneous Entry Set, Nephrostomy Catheter recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Sof-Flex Double Pigtail Ureteral Stent Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Kwart Retro-Inject Ureteral Stent Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Wire Guide, Guidewire, Global Product Number G14326 recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Urethral Dilator Set, Global Product No. G14185 recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Roadrunner Hydrophilic PC Wire Guide, Guidewire recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Bentson PTFE Wire Guide, Guidewire recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Angled Tip Ureteral Catheter Set, Ureteral Catheter recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Heavy Duty PTFE Wire Guide, Guidewire recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Percutaneous Malecot Nephrostomy Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Percutaneous Pigtail Nephrostomy Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Universa Soft Ureteral Stent recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Sof-Flex Multi-Lenqth Ureteral Stent Set recalled by Cook	Cook	Other	Nationwide
12 Feb 2020	CLASS II	Fixed Core Straight Safety Wire Guide, Guidewire recalled by Cook	Cook	Other	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

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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide