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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80919

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

Open FDA event record

Event summary

Timeline bucket
August 16, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Medtronic Vascular

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

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

Z-3253-2018
Recall number
Z-3253-2018
Initiated
August 16, 2018
Classification
Class III
Status
Terminated
Recalling firm
Medtronic Vascular
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.

Code information

UDI/GTIN: 20643169738717 Lot Number 60068186

Distribution pattern

CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand