CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report
Carto Vizigo 8.5F Bi-Directional Guiding Sheath recalled
Biosense Webster is recalling Carto Vizigo 8.5F Bi-Directional Guiding Sheath, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1677-2022
- FDA event ID
- 90647
- Recalling firm
- Biosense Webster, Irwindale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jun 2022
- FDA classified
- 2 Sep 2022
- Reported
- 14 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 2 Sep 2022 | Classified by FDA | +65 days |
| 14 Sep 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Where it was distributed
US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIowaIndianaMassachusettsMaineNew HampshireNew MexicoNew YorkOhioSouth CarolinaTennesseeTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
Which lots are affected?
UDI-DI: 10846835016253, Lot Number: 00002001
Where was it sold?
US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biosense Webster
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Varipulse Bi-Directional Ablation Catheter recalled by Biosense Webster | Biosense Webster | Other | 10 states |
| Device | CLASS II | Carto Vizigo Bi-Directional Guiding Sheath recalled by Biosense Webster | Biosense Webster | Other | Nationwide |
| Device | CLASS II | Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium) recalled | Biosense Webster | Labeling Errors | Nationwide |
| Device | CLASS II | Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small) recalled | Biosense Webster | Labeling Errors | Nationwide |
| Device | CLASS II | Carto Vizigo, Bi-Directional Guiding Sheath, 8.5F (medium) C3 recalled | Biosense Webster | Other | CA |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |