Cook Inc. Recalls PTFE Wire Guides Due to Loading Error Risk
Cook Inc. is recalling 3,929 PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where a mechanical error could lead to patient injury (introduction of a stiff tip), but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 3,929 units of PTFE Wire Guides, Global Product Number 638813 635413-10. 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, Germany, Japan, and the United Kingdom. The recall covers specific lot codes listed in the agency's official documentation.
Healthcare providers and facilities should stop using the affected PTFE Wire Guides immediately. Users should contact Cook Inc. for instructions on how to return the devices or obtain replacements. Patients who have had these devices used should consult their healthcare provider if they have concerns regarding the procedure.
The recalled product
- Product
- PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
- Manufacturer
- Cook Inc.
- Affected units
- 3,929
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.
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