BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Summary
The FDA issued a Class II for BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2 by Stryker Sustainability Solutions. Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lea.
Details
Source
Device Recall
External ID
Z-0085-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Lot/Code Info: UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
Quantity Affected: 10
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.
Distribution
US Nationwide distribution in the state of NJ.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-18
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Stryker Sustainability Solutions has 54 FDA actions in our database, including 42 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Sustainability Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Sustainability Solutions have FDA actions?
Stryker Sustainability Solutions has 54 FDA actions in our database, including 42 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0085-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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