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Devices
PTFE (Polytetrafluoroethylene) felt.
Model / Serial
Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
The product was distributed to hospitals nationwide.
Product Description
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, || M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
Manufacturer
Boston Scientific Scimed
1 Event
Recall of PTFE (Polytetrafluoroethylene) felt.
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Manufacturer
Boston Scientific Scimed
Manufacturer Address
Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
Source
USFDA
Language
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