Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
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 where sterility may be compromised, creating a risk of harm (infection) that has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 141 units of the NeuroPath 5Fx90 Guiding Catheter (Product Code: GHH509000000). The recall was initiated because the sterility of the device may be compromised due to a lack of package integrity. The product is intended for use in the coronary, peripheral, and neurovasculature for the intravascular introduction of interventional and diagnostic devices.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Austria, Belgium, Canada, Chile, Costa Rica, Czech Republic, Denmark, France, Germany, Great Britain/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland. The recall covers all unexpired lots of the product.
Healthcare providers and facilities should stop using the affected NeuroPath 5Fx90 Guiding Catheters and contact Codman & Shurtleff, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 141
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)
- All unexpired lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Codman & Shurtleff, 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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