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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94014

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 16, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Biosense Webster, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.

Z-1290-2024
Recall number
Z-1290-2024
Initiated
February 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Biosense Webster, Inc.
Quantity
853 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Code information

Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282

Distribution pattern

U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA, SC, AZ, MI KY, NJ, WI, IN, LA, TX, MA, OH, AR, MT, MO, VA, NC, TN, CA, MN, WV, CT, CO, IA, MD, ID, NM, NH, UT, GA, WA, NV, OK, KS, AK, NE, HI.