FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
- Recall number
- Z-0931-05
- Recalling firm
- Boston Scientific Scimed
- Product
- PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
- Status
- Terminated
- Initiated
- 2005-04-19
- Posted
- 2005-06-25
- Terminated
- 2006-10-03
- Reason
- Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
- Root cause
- Other
- Action
- Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.
- Quantity
- 290 packs containing 5 pieces of Felt.
- Distribution
- The product was distributed to hospitals nationwide.
- Lot, serial or model codes
- Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXZ
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28