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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95434

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

Open FDA event record

Event summary

Timeline bucket
September 20, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Maquet Cardiovascular, LLC

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

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

Z-0092-2025
Recall number
Z-0092-2025
Initiated
September 20, 2024
Classification
Class I
Status
Ongoing
Quantity
28,809 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

Code information

UDI-DI: VH-3000-W - 00607567700413, VH-3500 - 00607567701250; Lot Numbers: VH-3000-W: 3000365379, 3000382334, 3000392749; VH-3500: 3000333967 3000354228 3000364520 3000376542 3000384902 3000400713 3000339701 3000355224 3000365391 3000376883 3000385174 3000401094 3000340534 3000355369 3000366446 3000377320 3000385849 3000401623 3000341133 3000355798 3000366831 3000377699 3000386206 3000402378 3000341675 3000356048 3000367160 3000378079 3000386871 3000403161 3000342250 3000357837 3000367439 3000378654 3000387986 3000403837 3000342251 3000360574 3000367542 3000379282 3000387987 3000404029 3000343264 3000360576 3000367852 3000379691 3000388401 3000404374 3000343266 3000360775 3000368165 3000380264 3000388676 3000404720 3000344887 3000361036 3000368658 3000380475 3000389329 3000411951 3000345068 3000361423 3000369005 3000380671 3000392530 3000346640 3000361707 3000369122 3000381049 3000392531 3000351187 3000362064 3000369645 3000381287 3000393159 3000351376 3000362258 3000370069 3000381620 3000393427 3000351407 3000362671 3000370290 3000382054 3000393838 3000351619 3000362933 3000372257 3000382868 3000394234 3000351747 3000363162 3000375534 3000383367 3000395128 3000351860 3000363947 3000375776 3000383779 3000398856 3000352770 3000364082 3000376132 3000384088 3000399341 3000354226 3000364309 3000376388 3000384382 3000399911

Distribution pattern

Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.

Field note

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