Maquet Cardiovascular, LLC recalls Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy…
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural…
Read the official notice →- Date
- 2023-11-01
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision…
- Classification
- Class II
- Units
- Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Maquet Cardiovascular recalls
- 2024-01-24
USMaquet Cardiovascular, LLC recalls Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice →- 2023-12-27
- US
Maquet Cardiovascular, LLC recalls Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
The Positioner Arm may not tighten or lock during normal use.
- 2023-11-08
- US
Maquet Cardiovascular, LLC recalls Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box…
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA · DeviceMaquet Cardiovascular, LLCUS (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.Official notice → - 2023-08-09
- US
Maquet Cardiovascular, LLC recalls ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
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…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Bangladesh,…Official notice → - 2023-04-12
- US
Maquet Cardiovascular, LLC recalls VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Some batches of product were not sterilized to their minimum sterilization specification.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Brazil, China.Official notice → - 2023-03-22
- US
Maquet Cardiovascular, LLC recalls Fusion Bioline Vascular Graft, Part number M00201503046B0
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY,…Official notice →
Other drugs & medical recalls in the United States
- 2023-11-01
- US
GE Healthcare recalls Universal Viewer Workflow Manager, Image processing radiological system
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and…
FDA · DeviceGE HealthcareNationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO,…Official notice → - US
Smiths Medical ASD Inc. recalls Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under…
- US
GE Healthcare recalls Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and…
FDA · DeviceGE HealthcareUS and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile,…Official notice → - US
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and…
FDA · DeviceAcclarent, Inc.US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME,…Official notice → - US
SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
FDA · DeviceSynCardia Systems LLCUS: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi…Official notice → - US
B. Braun Medical, Inc. recalls 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to…
FDA · DeviceB. Braun Medical, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice →