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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85775

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

Open FDA event record

Event summary

Timeline bucket
May 22, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott

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

TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.

Z-2541-2020
Recall number
Z-2541-2020
Initiated
May 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Abbott
Quantity
84104 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter

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

High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter

Code information

All batch numbers with an expiration date of April 25, 2020

Distribution pattern

Worldwide distribution.