Class IIDeviceOngoing

Stryker Sustainability Solutions

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

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.

Details

Recall number: Z-0085-2027
Event ID: 99655
Recall initiated: Aug 18, 2026
Classified: Oct 5, 2026
Reported: Oct 14, 2026
Quantity: 10
Distribution: US Nationwide distribution in the state of NJ.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Tempe, AZ, United States
Lot / code info: UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026