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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82803

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

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Event summary

Timeline bucket
May 10, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Cardiocommand 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

CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia

Z-1773-2019
Recall number
Z-1773-2019
Initiated
May 10, 2019
Classification
Class III
Status
Terminated
Recalling firm
Cardiocommand Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible corrosion of the battery contact(s).

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

Possible corrosion of the battery contact(s).

Code information

Serial Numbers: 8059, 8060, 8022, 8063, 8211

Distribution pattern

US Nationwide distribution in the states of CT, VW, OH, IL, DE.

Field note

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