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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87033

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

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Event summary

Timeline bucket
December 15, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.

Z-0870-2021
Recall number
Z-0870-2021
Initiated
December 15, 2020
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.

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 (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.

Code information

GTIN 08714729936176, Lot Number H1937249

Distribution pattern

US Nationwide distribution including in the states of Tulsa, OK.