CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled
Stryker Sustainability Solutions is recalling Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f, Large 4.0, 10, 2-5, distributed nationwide in the US. The recall was initiated on 18 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0085-2027
- FDA event ID
- 99655
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2026
- FDA classified
- 5 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 18 Aug 2026 | Recall initiated by company | |
| 5 Oct 2026 | Classified by FDA | +48 days |
| 14 Oct 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Where it was distributed
US Nationwide distribution in the state of NJ.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
Where was it sold?
US Nationwide distribution in the state of NJ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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