CLASS II Device recall · Reported 27 Feb 2013 · FDA Enforcement Report
Neuropath 5Fx100 Guiding Cath ST Product recalled by Codman & Shurtleff
Codman & Shurtleff is recalling Neuropath 5Fx100 Guiding Cath ST Product, distributed nationwide in the US. The recall was initiated on 11 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0858-2013
- FDA event ID
- 64158
- Recalling firm
- Codman & Shurtleff, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2013
- FDA classified
- 20 Feb 2013
- Reported
- 27 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jan 2013 | Recall initiated by company | |
| 20 Feb 2013 | Classified by FDA | +40 days |
| 27 Feb 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility of device may be compromised due to lack of package integrity
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
Questions about this recall
Is Neuropath 5Fx100 Guiding Cath ST Product recalled?
Yes. Codman & Shurtleff recalled Neuropath 5Fx100 Guiding Cath ST Product on 11 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0858-2013.
Why was it recalled?
Sterility of device may be compromised due to lack of package integrity
Which lots are affected?
All unexpired lots
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | Codman EDS 3 Drainage System with Ventricular Catheter recalled | Codman & Shurtleff | Packaging Defects | Nationwide |
| Device | CLASS II | Codman EDS 3 Drainage System (no Ventricular Catheter) recalled | Codman & Shurtleff | Packaging Defects | Nationwide |
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