Chest Stabilization Device Latch May Fail During Cardiac Surgery
The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a surgical device with serious potential hazards including device component release into the patient and loss of organ stabilization during cardiac surgery. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular is recalling 785 units of the ACCESSRAIL Platform Standard Blade (Part Number SB-1000) and Deep Blades (Part Number C-DB-1000). These devices are components of a chest stabilization system used during cardiac and chest surgery.
The Standard Blade may not latch securely onto the Activator Drive. This may result in the inability to stabilize and position the heart, loss of stabilization during the procedure, release of a device component into the patient, and/or procedural delay or conversion to open surgery.
The recalled devices were distributed worldwide to the United States and 14 other countries including Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and the United Arab Emirates.
The recalled product
- Product
- ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- latch-failure
- device-component-release
- loss-of-stabilization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00607567700215
Distribution
Distributed nationwide across the United States.
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