The Recall Desk
HighFDA (Devices)·Z-1677-2022·Announced 2022-09-14

CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging

Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for sterile barrier compromise on a cardiovascular product. While no illnesses or deaths are reported in the source, the potential for infection from a compromised sterile barrier on a device used in cardiac procedures represents significant health risk.

Plain-English summary

Biosense Webster, Inc. is recalling 98 units of the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (Reference: D138501). The devices' outside packaging sustained water damage that may have compromised the sterile barrier protecting the product inside. A compromised sterile barrier could allow bacterial or other pathogenic contamination, creating a potential risk of infection for patients undergoing cardiac procedures.

The affected devices were distributed nationwide across 18 U.S. states: Alabama, Georgia, Arizona, Texas, Massachusetts, Virginia, New York, Maine, Florida, Iowa, New Mexico, New Hampshire, Tennessee, Wisconsin, Ohio, South Carolina, California, and Indiana. The recalled lot is identified as Lot Number 00002001, with UDI-DI 10846835016253.

Healthcare facilities that received these devices should immediately discontinue use and contact Biosense Webster regarding return or replacement procedures. Patients who may have undergone cardiac procedures using these devices and experience signs of infection (such as fever, redness, or discharge at the procedure site) should contact their healthcare provider promptly.

The recalled product

Product
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Manufacturer
Biosense Webster, Inc.
Category
Medical Device — Cardiovascular / Guiding Sheath
Hazard
  • sterile-barrier-compromise
  • infection-risk
  • water-damage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 10846835016253
  • Lot Number: 00002001

Distribution

Distributed nationwide across the United States.

Related recalls

Same category