Biosense Webster, Inc. recalls
Every recall we track for Biosense Webster, Inc. — 15 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Biosense Webster, Inc. peaked in 2017 (6); 15 since 2017.
All FDA recall records for Biosense Webster, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 6 | 0 | 0 | 6 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 2 | 1 | 0 | 3 |
| 2022 | 0 | 1 | 0 | 0 | 1 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 1 | 0 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Biosense Webster, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Biosense Webster, Inc. recalls
8 shown- Use cautionMedical device
Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based
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 WebsterJan 5, 2025 - Lower riskMedical device
Biosense Webster, Inc. recalls CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to
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 WebsterFeb 16, 2024 - Lower riskMedical device
Biosense Webster, Inc. recalls Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
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 WebsterFeb 21, 2023 - Use cautionMedical device
Biosense Webster, Inc. recalls CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into
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 WebsterJun 29, 2022 - Use cautionMedical device
Biosense Webster, Inc. recalls Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE
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 WebsterFeb 26, 2021 - Use cautionMedical device
Biosense Webster, Inc. recalls WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Biosense Webster recalls WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems (catalog numbers WCR1523, WCR2523) due to risk of device failure during recapture attempts.
Biosense WebsterMay 7, 2018 - Use cautionMedical device
Biosense Webster, Inc. recalls THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Biosense Webster recalls THERMOCOOL SF NAV catheters with specific model numbers due to Alert 402 causing potential unintended ablation areas during cardiac procedures.
Biosense WebsterSep 6, 2017 - Use cautionMedical device
Biosense Webster, Inc. recalls SMARTABLATE RF System Generator
Biosense Webster recalls SMARTABLATE RF System Generator (M490:006, M490007) due to risk of unintended RF energy delivery if foot pedal near Stereotaxis magnets.
Biosense WebsterJun 14, 2017
Biosense Webster, Inc. recall questions
How many recalls has Biosense Webster, Inc. had?
15 recalls from Biosense Webster, Inc. are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Biosense Webster, Inc. recall?
Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based, dated Jan 5, 2025. Every Biosense Webster, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Biosense Webster, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Biosense Webster, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.