Z-1677-2022Class II

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular...

Name: Z-1677-2022 CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular...
Creator: Biosense Webster, Inc.
Published: 2022-06-29
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2022-06-29 / Open, Classified / root cause: manufacturing process

FDA source

Biosense Webster, Inc. began a recall of CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart on 2022-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1677-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-29
Posted: 2022-09-02
Recalling firm: Biosense Webster Inc
Product: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 6/29/22, re call notices started being emailed and mailed to customers who were asked to do the following: 1) The notice should be forwarded to anyone in the facility that needs to be aware. 2) Identify affected devices, unbox devices, and destroy the devices. 3) Complete and return the Business Reply Form and send back the label on empty boxes to receive credit. 4) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 5) Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed. If you have additional questions about this letter, please email the recalling firm at [email protected]
Quantity in commerce: 98
Distribution: 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.
Product codes and lots: UDI-DI: 10846835016253, Lot Number: 00002001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1677-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1677-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-02

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)