Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f… recallZ-0085-2027 · Stryker Sustainability Solutions · initiated Aug 18, 2026
Open, Classified
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 Stryker Sustainability Solutions 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
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
FDA root cause category: Packaging process control
What the company is doing
On 8/18/2026, the recall notice was mailed to the customer asking them to do the following: 1) Inform individuals within your organization who need to be aware of this action. 2) Quarantine and return affected product to the firm. 4) Complete and return the Business Reply Form via email to [email protected] Questions can be directed to the firm via email, [email protected], or via phone 800-624-4422.
Recall details
- Recall number
- Z-0085-2027
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2026
- Posted by the FDA
- Oct 5, 2026
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 10
- Product code
- NLH
- FDA submissions
- K030187
- Distribution
- US Nationwide distribution in the state of NJ.
Product description
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Code information (models, lots, serial numbers)
UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED2 recalls0 reports
Other devices under the same FDA submission
11 devices cleared under K030187 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall18 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall3 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall1 report
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED2 reports
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 report
- N/AStryker Sustainability Solutions, Inc. · CATHETER, RECORDING, ELECTRODE, REPROCESSED1 report
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 16, 2026. Text above is shown as published by the FDA.
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