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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90887

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

Open FDA event record

Event summary

Timeline bucket
September 07, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Johnson & Johnson Surgical Vision, 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

THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.

Z-0169-2023
Recall number
Z-0169-2023
Initiated
September 07, 2022
Classification
Class II
Status
Ongoing
Quantity
91

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

Code information

UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L

Distribution pattern

Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.