Z-0497-2010

TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO...

Name: Z-0497-2010 TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO...
Creator: Ev3, Inc.
Published: 2009-11-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-11-06 / Terminated / root cause: design

FDA source

Ev3, Inc. began a recall of TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090... on 2009-11-06. The reason FDA records is "Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization". 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-0497-2010
Status: Terminated
Initiated: 2009-11-06
Posted: 2009-12-23
Terminated: 2011-01-05
Recalling firm: Medtronic, Inc.
Product: TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150. Intended to guide and support a guide wire during access of the vasculature.
Product code: DQY Catheter, Percutaneous
Reason for recall: Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700.
Quantity in commerce: 70
Distribution: Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI.
Product codes and lots: Lot #: 7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, and 7832205.

Product code DQY

K092299Class IITrailblazer Support CatheterEv3, Inc. / cleared 2009-08-07

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)