Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 6Fx100 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 medical device where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 129 units of the NEUROPATH 6Fx100 GUIDING CATH S2 (Product Code: GSM61000000). 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 are all unexpired lots. The 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 devices and contact Codman & Shurtleff, Inc. for further instructions on the recall.
The recalled product
- Product
- NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 129
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.
See all 24 products in this recall →Related recalls
Same manufacturer · Codman & Shurtleff, Inc.
See all →- ModerateCodman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
- HighCodman 3000 Series Refill Set Recalled for Leaking Needles
FDA (Devices) · 2015-06-03
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12