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 is classified as FDA Class II. The hazard involves a potential loss of sterility in an invasive medical device, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 46 units of the NeuroPath 5Fx100 Guiding Catheter (Product Code: GST51000000). The recall was initiated because the sterility of the device may be compromised due to a lack of package integrity. These catheters are 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, the Czech Republic, Denmark, France, Germany, Great Britain/UK, Ireland, Italy, Lithuania, Malaysia, the Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland. The recall covers all unexpired lots.
Healthcare providers and facilities should stop using the affected NeuroPath 5Fx100 Guiding Catheters immediately and contact Codman & Shurtleff, Inc. for instructions on returning the devices.
The recalled product
- Product
- NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 46
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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