Maquet 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…
Read the official notice →- Date
- 2024-01-24
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
- Classification
- Class I
- Units
- Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-07-17
USMaquet Cardiovascular, LLC recalls The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope.…
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between…
FDA · DeviceMaquet Cardiovascular, LLCNationwideForeign: AT DE DK ES GB HK IT NL ZAOfficial notice →- 2024-07-03
- US
Maquet Cardiovascular, LLC recalls The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2.…
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia Brazil,…Official notice → - 2024-01-24
- US
Maquet Cardiovascular, LLC recalls Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a…
- 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 → - 2023-11-01
- US
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…
FDA · DeviceMaquet Cardiovascular, LLCNationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TROfficial notice →
Other drugs & medical recalls in the United States
- 2024-01-24
- US
Philips North America recalls Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG…
FDA · DevicePhilips North AmericaDomestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY…Official notice → - US
Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in…
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS…Official notice → - US
Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a…
- US
Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- US
Globus Medical, Inc. recalls ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
FDA · DeviceGlobus Medical, Inc.Domestic distribution to the following states: CA, CO, MT, SC, WA.…Official notice → - US
Percussionaire Corporation recalls High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
FDA · DevicePercussionaire CorporationUS:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: NoneOfficial notice →