The Recall Desk
HighFDA (Devices)·Z-0970-2020·Announced 2020-02-12

Cook Inc. Recalls Urethral Dilation Balloon Catheters Due to Wire Guide Defect

Cook Inc. is recalling 13,388 Urethral Dilation Balloon Catheters 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 involves a medical device defect that poses a risk of physical harm (introduction of a stiff tip into a patient) but the source text does not report any specific injuries or illnesses, 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 the Urethral Dilation Balloon Catheter with Open Tip (Global Product No. G17844). 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 across the United States and internationally to numerous countries, including Australia, Canada, China, Germany, Japan, and the United Kingdom.

Healthcare providers and consumers should stop using the affected catheters immediately. The source text does not specify a particular action for consumers beyond the recall notice, but standard protocol for medical device recalls involves contacting the manufacturer or the FDA for instructions on return or disposal.

The recalled product

Product
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Manufacturer
Cook Inc.
Category
Medical Device — Urological Catheter
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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