Device recall
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
- Recall number
- Z-0085-2027
- Event id
- 99655
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Report date
- Oct 14, 2026
- Posted
- Oct 5, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Oct 5, 2026
- Product code
- NLH
- Device type
- Catheter, Recording, Electrode, Reprocessed
- Reason
- 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.
- Root cause
- Packaging process control
- Quantity
- 10
- Code info
- UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
- Distribution
- US Nationwide distribution in the state of NJ.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K030187
- Location
- Tempe, AZ, United States