Z-1285-2021Class II

Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE...

Name: Z-1285-2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE...
Creator: Biosense Webster, Inc.
Published: 2021-02-26
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2021-02-26 / Completed / root cause: design

FDA source

Biosense Webster, Inc. began a recall of Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product... on 2021-02-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1285-2021
Classification: Class II
Status: Completed
Initiated: 2021-02-26
Posted: 2021-03-22
Recalling firm: Biosense Webster Inc
Product: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
Product code: DYB Introducer, Catheter
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: On 2/26/21, Biosense Webster sent an "Urgent: Medical Device Correction" notification to all affected consignees via UPS. In addition, to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Precaution on inserting a dilator into VIZIGO Bi-Directional Guiding Sheath: " Use best practices for inserting or retracting any device at the hemostatic valve. " Do Not remove dilator or catheter rapidly. Damage to hemostatic valve may occur. " Aspirate slowly, only from the sideport. " Slowly remove or insert the dilator or other devices. " Once the sheath is inserted into the vasculature and the dilator is removed, aspirate until steady blood return is achieved prior to flushing or infusion. " Prior to inserting the device into the patient, pre-assemble sheath, dilator and stylet on the table. Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly. " Before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate. After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli. 2. Please review this letter carefully and share it with anyone in your facility that needs to be informed. 3. Please complete, sign, and return the Business Reply Form.
Quantity in commerce: 71,473 units
Distribution: Worldwide distribution.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1285-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1285-2021	Class II	Completed	Voluntary: Firm initiated	2021-03-31	2021-03-22
Z-1286-2021	Class II	Completed	Voluntary: Firm initiated	2021-03-31	2021-03-22
Z-1287-2021	Class II	Completed	Voluntary: Firm initiated	2021-03-31	2021-03-22

Product code DYB

K170997Class IICARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc. / cleared 2017-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)