TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane… recallZ-0497-2010 · Ev3, Inc. · initiated Nov 6, 2009
Terminated All recalls posted in December 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ev3, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0497-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 6, 2009
- Posted by the FDA
- Dec 23, 2009
- Recalling firm
- Ev3, Inc.
- Quantity
- 70
- Product code
- DQY
- FDA submissions
- K092299
- 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 description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
15 devices cleared under K092299 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TrailBlazer™ SC-035-135Ev3, Inc · Catheter, percutaneous20 reports
- TrailBlazer™ SC-018-150Ev3, Inc · Catheter, percutaneous8 reports
- TrailBlazer™ SC-035-090Ev3, Inc · CATHETER, PERCUTANEOUS7 reports
- TrailBlazer™ SC-018-135Ev3, Inc · Catheter, percutaneous5 reports
- TrailBlazer™ SC-035-090Ev3, Inc · Catheter, percutaneous4 reports
- TrailBlazer™ SC-018-135Ev3, Inc · CATHETER, PERCUTANEOUS4 reports
- TrailBlazer™ SC-035-135Ev3, Inc · CATHETER, PERCUTANEOUS4 reports
- TrailBlazer™ SC-014-150Ev3, Inc · Catheter, percutaneous3 reports
- TrailBlazer™ SC-035-150Ev3, Inc · Catheter, percutaneous3 reports
- TrailBlazer™ SC-035-135Medtronic, Inc. · Catheter, percutaneous3 reports
- TrailBlazer™ SC-018-150Ev3, Inc · CATHETER, PERCUTANEOUS3 reports
- TrailBlazer™ SC-014-135Ev3, Inc · Catheter, percutaneous2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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