Maquet recalls ACCESSRAIL Standard Blade (SB-1000) and Deep Blades (C-DB-1000) for potential instability during cardiac surgery, risking device release or procedural delays.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
Maquet is recalling two types of surgical blades for their chest stabilization system. The blades may not securely attach to the device, which could cause the device to become unstable during surgery, potentially releasing parts into the patient or causing delays.
The Standard Blade may not stay securely attached to the Activator Drive during surgery. This could lead to the device becoming unstable, possibly releasing components into the patient's body or causing the procedure to be delayed or canceled.
Surgical teams using the ACCESSRAIL Platform during cardiac or chest procedures are most at risk. Patients undergoing these surgeries with the recalled blades could face complications.
Check for the Standard Blade (Part Number SB-1000) or Deep Blades (Part Number C-DB-1000) in your chest stabilization system. These are used in cardiac and chest surgery procedures.
Ensure the blade securely latches onto the Activator Drive before use. If it doesn't stay attached, stop using it immediately.
The Standard Blade may not securely latch onto the Activator Drive, which could cause instability during surgery, potentially releasing device components into the patient or causing procedural delays.
The recall record does not specify a remedy, so contact Maquet directly for guidance on next steps.
Yes, the recall states that improper latching could lead to device release into the patient or procedural delays, which may affect patient safety.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2271-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2271-2023 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.
