Maquet recalls aortic arterial cannulas with potential 3/8-inch de-airing plugs that could break during removal, causing injury during cardiopulmonary bypass procedures.
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.
Maquet is recalling aortic arterial cannulas that may have de-airing plugs prone to breaking during removal. This could cause injury during cardiopulmonary bypass procedures, so affected users should stop using the device immediately.
The de-airing plugs may break during removal from the arterial cannula, potentially causing injury to the user or patient during cardiopulmonary bypass procedures. This risk occurs when the plug is removed from the cannula during surgery.
Healthcare professionals using the recalled cannulas for cardiopulmonary bypass procedures are most at risk. Patients undergoing surgery with these cannulas could be affected.
Check for the part number 701002246 and article number A22-7107 on the cannula packaging. The product was sold with UDI code 04037691123813 and lot numbers 92181729 or 92181287.
Immediately stop using the recalled aortic arterial cannula if it has the part number 701002246 and article number A22-7107.
The recalled model is Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector and part number 701002246.
Check for the part number 701002246 and article number A22-7107 on the packaging, or look for UDI code 04037691123813 with lot numbers 92181729 or 92181287.
Stop using it immediately and contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2160-2018 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2160-2018 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
