Codman Neuropath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling Neuropath 6Fx90 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 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 64 units of the Neuropath 6Fx90 Guiding Cath S2 (Product Code: GSM60900000). The recall covers all unexpired lots of this medical 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 defect poses a risk of infection if the non-sterile device is used in a sterile procedure.
The affected products 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. 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 S2 Product Code: GSM60900000 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
- 64
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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