CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag
Maquet Cardiopulmonary Ag is recalling Aortic Arterial Cannula (O.D.), distributed in Puerto Rico, Virginia. The recall was initiated on 14 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2159-2018
- FDA event ID
- 80076
- Recalling firm
- Maquet Cardiopulmonary Ag, Rastatt, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 May 2018
- FDA classified
- 11 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 14 May 2018 | Recall initiated by company | |
| 11 Jun 2018 | Classified by FDA | +28 days |
| 20 Jun 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Aortic Arterial Cannula (O.D.) recalled?
Yes. Maquet Cardiopulmonary Ag recalled Aortic Arterial Cannula (O.D.) on 14 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2159-2018.
Why was it recalled?
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.
Which lots are affected?
UDI CODE: 04037691085555, Lot Number: 92196585
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Cardiopulmonary Ag
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cardiohelp System HKH 8820 Wall Holder recalled | Maquet Cardiopulmonary Ag | Device Malfunction | IL, MO |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary Ag | Device Malfunction | PR, VA |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary Ag | Device Malfunction | PR, VA |
| Device | CLASS II | Cardiohelp Gas Bottle Holder HKH 8880, Product recalled | Maquet Cardiopulmonary Ag | Device Malfunction | MO |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |