Every recall we track for Biosense Webster, Inc. — 15 in all — plus the complaints and injury reports the public filed about them.
Biosense Webster recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201 due to observed trend of neurovascular events. Affected units include specific batch numbers and product codes.
Biosense Webster recalls CARTO VIZIGO Bi-Directional Guiding Sheath (REF D128502) produced with a manufacturing mix-up during validation. Affected units may have been inadvertently mixed into main production. Contact for remedy details.
Biosense Webster recalls specific Carto Vizigo Bi-Directional Guiding Sheaths due to incorrect labeling on carton vs. inner pouch. Affected units have lot #50000224 and UDI 10846835016277. No immediate action needed as this is a labeling issue, not a safety hazard.
Biosense Webster recalls specific Carto Vizigo Bi-Directional Guiding Sheaths due to incorrect labeling on carton versus inner pouch. This mismatch may cause confusion during medical procedures. Affected units include lot #00002137 with UDI 1084683:5016253.
Biosense Webster recalls CARTO VIZIGO 8.:5F Bi-Directional Guiding Sheaths with water damage risk. Compromised sterile barrier may cause infection. Affected units have specific UDI-DI and lot numbers.
Biosense Webster recalls specific cardiac sheaths for potential minor bleeding or embolism if hemostatic valve dislodges during use. Affected models include 8.1F (medium) C3, REF: D138502, CE 2797, sold for cardiac procedures.
Biosense Webster recalls specific cardiac sheaths due to potential hemostatic valve dislodgement during use, risking minor bleeding or embolism. Affected units include 8.5F (SMALL) C3 models with REF D138501.
Biosense Webster recalls specific cardiac sheaths for potential minor bleeding or embolism if the hemostatic valve dislodges during use. Affected models include 8. 5F (Large) C3, REF: D138503.
Biosense Webster recalls WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems (catalog numbers WCR1523, WCR2523) due to risk of device failure during recapture attempts.
