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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93462

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2023
Product types
Device
Classifications
Class III
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

CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012

Z-0595-2024
Recall number
Z-0595-2024
Initiated
November 14, 2023
Classification
Class III
Status
Ongoing
Quantity
1594 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CARDIOHELP-i System was not properly tested to measure leakage current

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CARDIOHELP-i System was not properly tested to measure leakage current

Code information

UDI-DI: 04058863074863; 04037691658384 All serial numbers up to and including 90415172

Distribution pattern

Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen