TemporaryFDAOngoing
Can cause harm that is usually temporary.
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Check the device or its packaging for
UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
- Why
- 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.
- Distributed
- US Nationwide distribution in the state of NJ.
- Company
- Stryker Sustainability Solutions
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0085-2027 · retrieved 5 October 2026
Read the official notice