Reported Feb 15, 2017 · Terminated
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a…
AtriCure, 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: AtriCure, Inc. · 7555 Innovation Way · Mason, OH · 45040-9695
Is this the product you have?
- AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.
- Lot codes and dates
- Model Numbers
PRO235PRO240PRO245
- PRO250 Lot Numbers67102 to 68418
- Model Numbers
- Amount recalled
- 464 units
Where it was sold
Why it was recalled
A complaint of the PRO2 jaw breaking prior to surgery being performed.
This product could cause temporary or reversible health problems — stop using it.
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