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.
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 high-risk medical device where sterility may be compromised, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 867 units of the NeuroPath 6Fx100 Guiding Catheter (Product Code: GMD60900000). 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 package integrity. This issue could potentially affect the safety of the device when used in patients.
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 further instructions.
The recalled product
- Product
- NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 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
- 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.
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
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- 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
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
FDA (Devices) · 2019-10-09
- ModerateStryker Neurovascular Recalls Guider Softip XF Guide Catheters
FDA (Devices) · 2016-11-09
- SevereMedtronic Vascular Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls 10 Units of Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09