Biosense Webster, Inc. recalls Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheat
Recalled Product
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
Hazard / Issue
There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
Issued by
FDA
Were you affected by this recall?
If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.
Looking for safe alternatives?
Browse certified-safe products in this category on Amazon →
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime