The Recall Desk
HighFDA (Devices)·Z-0973-2020·Announced 2020-02-12

Cook Inc. Recalls C-Flex Double Pigtail Ureteral Stent Sets

Cook Inc. is recalling C-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of physical harm to patients (introduction of a stiff tip instead of a flexible one), but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 13,388 units of the C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364, G14365, and G14367. The recall is due to a defect where the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip.

The affected products were distributed domestically to the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom. Specific lot codes associated with the recall include NS7953136, NS8169661, NS8180857, NS8169662, NS8180858, NS8180859, and NS8180860.

Healthcare providers and facilities should stop using the affected stent sets and contact Cook Inc. for instructions on returning the products. Patients who have had these stents placed should consult their healthcare provider regarding the potential risk of the stiff wire tip being introduced during the procedure.

The recalled product

Product
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Manufacturer
Cook Inc.
Category
Medical Device — Urological Stents
Hazard
Affected units
13,388

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • NS7953136 NS8169661 NS8180857 NS8169662 NS8180858 NS8180859 NS8180860

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

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