Cope Nitinol Guidewire Recalled Due to Packaging Sterility Breach
Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) devices because the packaging's chevron seal may be completely breached, potentially compromising sterility. The recall affects 1,501 US units and 380 international units.
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: This FDA Class II medical device involves a theoretical sterility risk from a packaging defect with no reported illnesses. It qualifies as a risk-of-harm product without reported injury, meeting the rubric criterion for High severity.
Plain-English summary
Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) Nitinol Guidewire devices. The recall affects three product variants with expiration dates ranging from June 23, 2027, to July 7, 2027.
The recall is due to a potential complete breach of the chevron seal on the device packaging. Cook Medical identified that this packaging defect may compromise the sterility of the devices.
Approximately 1,501 units were distributed in the United States and 380 units were distributed internationally. The devices are in use across healthcare settings nationwide and worldwide.
Patients and healthcare providers who have received these devices should contact Cook Incorporated for replacement or disposal instructions. Healthcare facilities should immediately stop using affected lots and remove them from inventory.
The recalled product
- Product
- Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Guidewire
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Cook Incorporated 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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