AESDEX recalls Cardica C-Port Flex-A PLUS Distal Anastomosis Systems due to potential handle damage and plastic fragments after pressurization, which could cause injury during medical procedures.
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 Cardica C-Port Flex-A PLUS Distal Anastomosis Systems because pressurizing the device may damage its handle mechanism, causing loud noises and plastic fragments to disperse. This poses a risk of injury during medical procedures if the device fails unexpectedly.
Pressurizing the device during use can cause the handle mechanism to break, producing loud noises and plastic fragments that may injure the user or patient. This risk is specific to the device's design and how it is used in medical procedures.
Medical professionals using the Cardica C-Port Flex-A PLUS Distal Anastomosis System for coronary procedures are most at risk. Patients receiving these procedures may also be affected if the device malfunctions.
Check for the catalog number FG-000150 on the device. The affected units were sold with lot numbers 141118H through 180103B.
Inspect the handle mechanism for signs of damage, loud noises, or plastic fragments after pressurization.
The device may become damaged during use, causing potential injury. Users should check for signs of damage before proceeding.
The official recall does not specify a remedy, so users should check the device for damage and contact AESDEX for further guidance.
Yes, affected lot numbers include 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, and 180103B.
We’ve drafted a message you can send AESDEX to request your refund or repair — edit it as you like.
Subject: Recall Z-2434-2018 — AESDEX AESDEX Hello, I own a AESDEX that is covered by recall Z-2434-2018 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.
