BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
FDA Recall Z-0085-2027 · Posted 2026-10-05
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Recalling FirmStryker Sustainability Solutions
Recall StatusOpen, Classified
Product CodeNLH
Date Initiated2026-08-18
Product Quantity10
Reason for Recall
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.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution in the state of NJ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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