Z-0260-2008

Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length...

Name: Z-0260-2008 Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length...
Creator: Boston Scientific Target
Published: 2007-07-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-07-11 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Target began a recall of Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number... on 2007-07-11. The reason FDA records is "Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0260-2008
Status: Terminated
Initiated: 2007-07-11
Posted: 2007-11-24
Terminated: 2007-12-05
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
Product code: DQY Catheter, Percutaneous
Reason for recall: Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
Quantity in commerce: 49 units
Distribution: Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
Product codes and lots: LOT 9311878, Catalogue #10142, Material #M003101420, Expires 10-JAN-2010

Product code DQY

K980453Class IISchneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. / cleared 1998-08-11

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)