Maquet Cardiovascular, LLC VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
UDI-DI: 00607567700345, Lot Numbers: 3000274687
Products Sold
UDI-DI: 00607567700345; Lot Numbers: 3000274687
Maquet Cardiovascular, LLC is recalling VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W due to Some batches of product were not sterilized to their minimum sterilization specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some batches of product were not sterilized to their minimum sterilization specification.
Recommended Action
Per FDA guidance
An Urgent Medical Device Removal notification letter dated 3/3/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro lot(s) affected by this recall. Please, note that Distributed Affected Lot Number(s) appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of the Hemopro with the product code/lot number(s) listed in this notice. " Should you have any affected product lot(s) as listed in this notification, please stop using and remove the complete device from areas of use. If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. " Please forward this information to all current and potential Hemopro and Hemopro 2 users within your hospital / facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact Getinge Customer Service at 888-880-2874 between the hours of 6:00 a.m. and 5:00 p.m. Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. " Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet Cardiovascular, LLC /Getinge by e-mailing a scanned copy to Hemopro2023Sterility.act@getinge.com or by faxing the form to 1-800-385-0294 . We apologize for any inconvenience this recall may cause. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026