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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80076

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 14, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Cardiopulmonary Ag

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

3 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 3

Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass

Z-2159-2018
Recall number
Z-2159-2018
Initiated
May 14, 2018
Classification
Class II
Status
Terminated
Recalling firm
Maquet Cardiopulmonary Ag
Quantity
40 US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

Code information

UDI CODE: 04037691085555, Lot Number: 92196585

Distribution pattern

Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.

device · product 2 of 3

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

Z-2160-2018
Recall number
Z-2160-2018
Initiated
May 14, 2018
Classification
Class II
Status
Terminated
Recalling firm
Maquet Cardiopulmonary Ag
Quantity
470 US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

Code information

UDI CODE: 04037691123813, Lot Number: 92181729 and 92181287

Distribution pattern

Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.

device · product 3 of 3

Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass

Z-2161-2018
Recall number
Z-2161-2018
Initiated
May 14, 2018
Classification
Class II
Status
Terminated
Recalling firm
Maquet Cardiopulmonary Ag
Quantity
150 US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

Code information

UDI CODE: 04037691239804, Lot Number: 92180017, 92183437 and 92184278

Distribution pattern

Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.