Boston Scientific Scimed PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
Brand
Boston Scientific Scimed
Lot Codes / Batch Numbers
Lot Numbers: 7337514, 7337515, 7337516, 7337717, 7350604, 7356745, 7356747, 7359759, 7359760, 7360535, 7360536, 7384480, 7384483, 7384484, 7384485, 7384486, 7384487, 7412113.
Products Sold
Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.
Boston Scientific Scimed is recalling PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002 due to Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
Recommended Action
Per FDA guidance
Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026