Z-0931-05

PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821...

Name: Z-0931-05 PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821...
Creator: Boston Scientific Scimed
Published: 2005-04-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-04-19 / Terminated

FDA source

Boston Scientific Scimed began a recall of PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861... on 2005-04-19. The reason FDA records is "Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0931-05
Status: Terminated
Initiated: 2005-04-19
Posted: 2005-06-25
Terminated: 2006-10-03
Recalling firm: Boston Scientific Corporation
Product: PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
FDA 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 in commerce: 290 packs containing 5 pieces of Felt.
Distribution: The product was distributed to hospitals nationwide.
Product codes and lots: Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.

Product code DXZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)