Agency classClass IIOur severity:High FDA (Devices)·Z-2271-2023·Announced 2023-08-09

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Cardiac Stabilization System
Hazard: latch-failure
device-component-release
loss-of-stabilization
Affected units: 785

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.

Part of a larger recall action

This product is one of 4 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · latch failure