Codman NeuroPath Guiding Catheter Recalled for Sterility Compromise
Codman & Shurtleff is recalling 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 is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Codman & Shurtleff, Inc. is recalling the NeuroPath 5Fx90 Guiding Catheter (Product Code: GCB50900000). The recall involves 5 units of the device, which is intended for use in the coronary, peripheral, and neurovasculature for the intravascular introduction of interventional and diagnostic devices.
The recall was initiated because the sterility of the device may be compromised due to a lack of package integrity. This issue affects all unexpired lots of the product.
The affected devices 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. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 5
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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