Codman NeuroPath Guiding Catheter Recalled for Packaging Integrity Issues
Codman & Shurtleff is recalling 867 NeuroPath guiding catheters because packaging defects may compromise sterility. The devices were distributed worldwide.
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 a medical device used in vascular procedures, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 867 units of the NEUROPATH 6Fx90 GUIDING CATH MPC (Product Code: GMC60900000). The recall affects all unexpired lots of the device. These catheters are 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 packaging integrity. This defect could potentially allow contamination of the sterile device.
The affected products were distributed 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. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 867
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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