CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag
Maquet Cardiopulmonary 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-2160-2018
- FDA event ID
- 80076
- Recalling firm
- Maquet Cardiopulmonary, 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 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
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
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: 04037691123813, Lot Number: 92181729 and 92181287
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 80076| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA | |
| CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
More recalls from Maquet Cardiopulmonary
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Sprinter Cart/Sprinter Cart XL Infusion Pole recalled | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Cardiohelp System HKH 8820 Wall Holder recalled | Maquet Cardiopulmonary | Device Malfunction | IL, MO |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |