Stryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F,
See all recalls from Stryker Sustainability Solutions →Recalled Product
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for BARD EP XT DECAPOLAR →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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