The Recall Desk
HighFDA (Devices)·Z-0975-2020·Announced 2020-02-12

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

Cook Inc. is recalling Sof-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

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 is classified as FDA Class II and involves a risk of physical injury from a stiff tip entering the patient, but the source text does not report any specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 13,388 units of Sof-Flex Double Pigtail Ureteral Stent Sets, identified by Global Product Numbers G15076, G14906, G14840, G14865, and G17128. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is due to a risk that the wire guide may be incorrectly loaded into the wire guide holder. This error could 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 across the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. Healthcare providers and patients should contact Cook Inc. for further instructions regarding the recall.

The recalled product

Product
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Manufacturer
Cook Inc.
Category
Medical Device — Urological Stents
Hazard
Affected units
13,388

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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