FDAJune 28, 2023device
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
maquet cardiovascularmaquet
UPCs
00607567700536
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;2026-01-09
- FDAHeartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System. Intravascular anastomosis occluder.2025-08-15
- FDAVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting T...2025-08-06
- FDACorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.2025-07-14
- FDASprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.2025-06-27
- FDAServo-n Ventilator System. Model Number: 6694800.2025-05-30
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