Reported Nov 11, 2015 · Terminated

Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the…

Medtronic Inc.

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: Medtronic Inc. · 8200 Coral Sea St Ne · Saint Paul, MN · 55112-4391

Is this the product you have?

  • Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.
Lot codes and dates
  • Lot U531
Amount recalled
64 units

Where it was sold

Why it was recalled

64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

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 Mar 9, 2016 · Data as of Sep 19, 6:00 PM UTC

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