Agency classClass IIOur severity:High FDA (Devices)·Z-0853-2013·Announced 2013-02-27

Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

Codman & Shurtleff is recalling NeuroPath 5Fx100 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 infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Codman & Shurtleff, Inc. is recalling 5 units of the NeuroPath 5Fx100 Guiding Catheter (Product Code: GCB51000000). The recall is due to a potential lack of package integrity, which may compromise the sterility 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 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 devices and contact Codman & Shurtleff for further instructions on return or replacement. Patients who have had these devices used should consult their healthcare provider if they have concerns regarding infection or other complications.

The recalled product

Product: NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Manufacturer: Codman & Shurtleff, Inc.
Category: Medical Device — Catheter
Hazard: sterility-compromise
infection-risk
Affected units: 5

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 →

Same manufacturer · Codman & Shurtleff, Inc.

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Same hazard · sterility compromise