EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation… recallZ-1647-2012 · Biosense Webster, Inc. · initiated Dec 15, 2007
Terminated All recalls posted in May 2012
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 Biosense Webster, 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
The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
FDA root cause category: Incorrect or no expiration date
What the company is doing
The firm, Biosense Webster, sent a "Medical Device-Voluntary Field Removal" letter dated December 17, 2007 to its customer. The letter identified the product, problem and an action to be taken. The customer was instructed to complete and return the Product Voluntary Field Removal Certification Form via fax to Quality Compliance at (909) 839-7207or mail using the enclosed self-addressed stamped envelope. If you have additional questions, please follow up with your local Biosense Webster representative.or contact Customer Service at (909) 839-8500.
Recall details
- Recall number
- Z-1647-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 15, 2007
- Posted by the FDA
- May 22, 2012
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 1 unit
- Product code
- DRF
- FDA submissions
- K090898, K101345
- Distribution
- Nationwide distribution: CA only.
Product description
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
Code information (models, lots, serial numbers)
Lot Number: 13140790A
Other devices under the same FDA submission
4 devices cleared under K090898, K101345 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Webster CS BD710DF282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING21 reports
- Webster CS BD710FJ282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths17 reports
- Webster CS BD710DF282RTSBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING16 reports
- Webster CS BD710FJ282RTSBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death11 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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