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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92502

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

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Event summary

Timeline bucket
June 12, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
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

Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

Z-2110-2023
Recall number
Z-2110-2023
Initiated
June 12, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott
Quantity
675 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

Code information

UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.

Field note

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