Maquet 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…
Read the official notice →- Date
- 2024-07-17
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The…
- Classification
- Class II
- Units
- NationwideForeign: AT DE DK ES GB HK IT NL ZA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-15
USMaquet Cardiovascular, LLC recalls VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery…
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Australia, Austria,…Official notice →- 2024-11-27
- US
Maquet Cardiovascular, LLC recalls Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Albania, Algeria,…Official notice → - 2024-11-06
- US
Maquet Cardiovascular, LLC recalls VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution. US Nationwide. Brazil, China, and Hong Kong.Official 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…
- US
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…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-24
- US
- 2024-07-17
- US
Fresenius Medical Care Holdings, Inc. recalls RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution. International: Canada.Official notice → - US
Baxter Healthcare Corporation recalls Braun Thermoscan¿ PRO 6000 Ear Thermometer
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
FDA · DeviceBaxter Healthcare CorporationDistributed to United States, Canada, Australia, Malaysia, New Zealand,…Official notice → - US
MICROspecialties, Inc. recalls Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
- US
Barco N.V. recalls MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection…
- US
Integra LifeSciences Corp. recalls AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.