Stryker BARD EP XT Decapolar Catheter recalled for breached sterile barrier risk
What this means
Stryker Sustainability Solutions is recalling a specific lot of BARD EP XT Decapolar Steerable diagnostic catheters (Reference 201007) used in heart rhythm procedures. Some units may have a compromised sterile barrier on the primary pouch packaging, which could allow contamination if the catheter is used. This poses a risk of particle buildup, infection, or blood clots.
- If you have this catheter (Lot 5640704, Serial 5097742), do not use it.
- Contact Stryker Sustainability Solutions for instructions on return or replacement.
- If the catheter was already used, consult with your healthcare provider about potential monitoring.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2027More Stryker recalls
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