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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82319

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

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Event summary

Timeline bucket
March 04, 2019
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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.

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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

Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

Z-1069-2019
Recall number
Z-1069-2019
Initiated
March 04, 2019
Classification
Class III
Status
Ongoing
Quantity
2917 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

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Inspect official wording and provenance

Reason for recall

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

Code information

UDI 00643169522572 All lot numbers distributed in the past eighteen (18) months and all newly manufactured without the updated IFU are affected until product with the updated Instruction for Use (IFU) is available.

Distribution pattern

International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.