AESDEX recalls Cardica C-Port xA PLUS Anastomosis System (FG-000100) due to potential handle damage and plastic fragments after pressurization. Affected units include specific lot numbers from 2014-2017.
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
AESDEX is recalling its Cardica C-Port xA PLUS Anastomosis System because pressurization can damage the handle mechanism, causing loud noises and plastic fragments. This poses a risk of injury during medical procedures.
Pressurizing the device during medical procedures can cause the handle mechanism to break, producing loud noises and plastic fragments that could injure the user or patient. The system is used to connect small blood vessels during heart surgery.
Medical professionals using the Cardica C-Port xA PLUS Anastomosis System for heart surgery are most at risk. Patients undergoing procedures with this device may also be affected.
Check for the catalog number FG-000100 on the device. Affected units include specific lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A, sold between 2014 and 2017.
Look for the lot numbers listed: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A on the device packaging or label.
Reach out to AESDEX for further instructions on handling the device if it is affected.
Yes, the Cardica C-Port xA PLUS Anastomosis System is used to create connections between small blood vessels during heart surgery.
Pressurization can cause the handle mechanism to damage, producing loud noises and plastic fragments that may injure the user or patient.
Check for the lot numbers: 141031D, 150720K, 160317A, 160722E, 170223E, 170509G, 171012A, which were sold between 2014 and 2017.
We’ve drafted a message you can send AESDEX to request your refund or repair — edit it as you like.
Subject: Recall Z-2433-2018 — AESDEX AESDEX Hello, I own a AESDEX that is covered by recall Z-2433-2018 from AESDEX. 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.
