Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns
Codman & Shurtleff is recalling 1,548 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, posing a risk of harm (infection) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 1,548 units of the NeuroPath 6Fx100 Guiding Catheter (Product Code: GMD61000000). The recall is due to a potential 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 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.
Healthcare providers and facilities should stop using the affected NeuroPath 6Fx100 Guiding Catheters and contact Codman & Shurtleff, Inc. for further instructions on the return or disposal of the devices.
The recalled product
- Product
- NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 1,548
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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