Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter
The diagnostic EP catheter may have a breached sterile barrier, which could lead to particulate embolization, infection, or thrombus.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Stryker Sustainability Solutions recalled the Bard EP XT Decapolar Steerable, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007, beginning August 18, 2026, because the 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. The FDA added the recall to its Enforcement Report on October 5, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and reference number listed under your product.
Bard EP XT Decapolar Steerable, Diagnostic EP Catheter, 6F, Large 4.0, 10, 2-5-2MM
- UDI-DI
- 00885825003838
- Reference number
- 201007
- Lot
- 5640704
Details
- Company began the recall
- Event ID
- 99655
- Company
- Stryker Sustainability Solutions
- Hazard
- Sterility failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
