CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report

RunWay Guide Catheter, UPN H749389696640 recalled by Boston Scientific

Boston Scientific is recalling RunWay Guide Catheter, UPN H749389696640, distributed in Texas. The recall was initiated on 3 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes2013040058

Quantity recalled7

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-1164-2014
FDA event ID: 67658
Recalling firm: Boston Scientific, Maple Grove, MN
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2014
FDA classified: 10 Mar 2014
Reported: 19 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

3 Mar 2014	Recall initiated by company
10 Mar 2014	Classified by FDA	+7 days
19 Mar 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.

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

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

Where it was distributed

TX and Russia

Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

2013040058

Where was it sold?

TX and Russia

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 26 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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