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Stryker Sustainability Solutions: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007

Medical DevicesSource: FDA (device) · Date: 2026-10-14

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Stryker Sustainability Solutions
Product
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of NJ.
Recall initiated
2026-08-18
Code info
UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
Product quantity
10
Voluntary mandated
Voluntary: Firm initiated
City
Tempe
State
AZ
Country
United States
Event id
99655
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