Reported Nov 12, 2014 · Terminated

St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

St Jude Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: St Jude Medical · 1 Saint Jude Medical Dr · Saint Paul, MN · 55117-1789

Is this the product you have?

  • St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Lot codes and dates
  • Batch # 4671318
Amount recalled
26

Where it was sold

Why it was recalled

St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 10, 2014 · Data as of Sep 19, 6:04 PM UTC

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