Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 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 risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 32 units of the NEUROPATH 5Fx100 GUIDING CATH S2 (Product Code: GSM51000000). The recall is due to a lack of package integrity, which may compromise the sterility of the device. The product is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional and diagnostic devices.
The affected units are all unexpired lots. Distribution was worldwide, including the United States (nationwide) 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.
Healthcare providers and consumers should stop using the affected devices and contact Codman & Shurtleff, Inc. for further instructions on return or replacement.
The recalled product
- Product
- NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 32
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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