Z-0087-2010

Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway...

Name: Z-0087-2010 Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway...
Creator: Cordis Corporation
Published: 2009-10-15
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2009-10-15 / Terminated / root cause: design

FDA source

Cordis Corporation began a recall of Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis... on 2009-10-15. The reason FDA records is "Cordis has received complaints of stretching or fracture of the sheath shaft during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0087-2010
Status: Terminated
Initiated: 2009-10-15
Posted: 2009-11-05
Terminated: 2013-08-12
Recalling firm: Cordis US Corp.
Product: Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
Product code: DYB Introducer, Catheter
Reason for recall: Cordis has received complaints of stretching or fracture of the sheath shaft during use.
Root cause tag: design
FDA root cause: Component design/selection
Action: A Medical Device Recall letter dated October 19, 2009 was issued to consignees by sending an overnight letter to each account. The letter described the affected device, issue and actions for customers. A Cordis Corporation representative will follow-up and contact consignees as necessary to facilitate obtaining signature, faxing the acknowledgement form to the Cordis Corporation, collecting and returning units. A press release from the Cordis Corporation announced a nationwide recall of the CROSSOVER Sheath Introducer available on (http://www.webwire.com/ViewPressRel.asp?aId=106460). In addition to the local sales representative, customers may contact the special Customer Service number at 1-866-854-1672, Monday through Friday from 8:30 a.m. to 8:00 p.m. Eastern Standard Time, if you have any additional questions relative to product return or alternate product.
Quantity in commerce: 2,362 units
Distribution: Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.
Product codes and lots: Catalog Number: 403545S, Lot Numbers: U0000027, U0000041 and U0000047; Catalog Number: 403585S, Lot Number U0000025; Catalog Number: 403645S, Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052; Catalog Number: 403685S, Lot Numbers U0000033, U0000042 and U0000050; Catalog Number: 403745S, Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and Catalog Number: 403785S, Lot Numbers U0000037 and U0000046.

Product code DYB

K083269Class IICrossoverThomas Medical Products, Inc. / cleared 2009-02-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)