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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94082

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

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Event summary

Timeline bucket
February 12, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

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

Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

Z-1302-2024
Recall number
Z-1302-2024
Initiated
February 12, 2024
Classification
Class I
Status
Ongoing
Quantity
461 devices

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error in manufacturing

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

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

Code information

GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976

Distribution pattern

Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan