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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93772

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

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Event summary

Timeline bucket
December 28, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Maquet Medical Systems USA

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

Bubble Sensor (REF: 70105.5720)

Z-1053-2024
Recall number
Z-1053-2024
Initiated
December 28, 2023
Classification
Class II
Status
Ongoing
Quantity
274 units (70 US, 204 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

Code information

Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148; SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097;

Distribution pattern

AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.

Field note

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