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Vasoview Hemopro recallZ-2176-2024 · Maquet Cardiovascular, LLC · initiated May 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

Consignees were mailed an URGENT MEDICAL DEVICE - CORRECTION notice, dated 5/17/24. In the notice consignees are instructed to make users aware of the additional safety information provided in the notification by forwarding the notice to users in their facility and locations where devices are stored. Additionally, consignees are asked to return the provided response form by email to [email protected] or by fax to 800-892-0487. Getinge will be updating the Instructions for Use (IFU) of devices to include the additional safety information related to fluid ingress. Questions can be directed to Customer Support at 888-880-2874, Monday through Friday from 6:00 AM to 5:00 PM PST. UPDATE: On 07/11/2025 an updated Urgent Medical Device Correction Update letter was posted on Getinge.com and sent to consignees via letter. The updated communication informs users that the Instructions for Use (IFU) for the Vasoview Hemopro 2 EVH System has been revised to include warnings and precautions regarding fluid ingress into the handle of the Harvesting Tool. Consignees were instructed to review the updated IFU, view the training video linked in the letter, complete and return the Medical Device Correction Response form, and notify customers if product was further distributed.

Recall details

Recall number
Z-2176-2024
Status
Open, Classified
Initiated by the company
May 17, 2024
Posted by the FDA
Jun 24, 2024
Recalling firm
Maquet Cardiovascular, LLC
Quantity
37,186 units
Product code
GEI
FDA submissions
K153194
Distribution
Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom.

Product description

The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model No. VH-3500, VH-3000-W; UDI: 00607567701250, 00607567700345; Lot No. 3000314373, 3000314821, 3000316023, 3000316024, 3000316027, 3000317501, 3000317575, 3000317576, 3000318302, 3000318901, 3000320140, 3000320141, 3000320773, 3000321483, 3000321723, 3000323214, 3000324397, 3000324409, 3000325013, 3000325249, 3000325689, 3000325776, 3000328206, 3000328561, 3000328562, 3000329723, 3000330445, 3000331131, 3000331388, 3000332428, 3000332510, 3000332993, 3000333524, 3000333829, 3000333956, 3000333967, 3000334315, 3000335670, 3000336708, 3000337272, 3000339701, 3000340534, 3000341133, 3000341675, 3000342250, 3000342251, 3000343264, 3000343266, 3000344887, 3000351187, 3000352770, 3000354226, 3000354228, 3000355224, 3000355369, 3000355798, 3000356048, 3000357837, 3000360574, 3000360576, 3000360775, 3000361036, 3000361423, 3000361707, 3000362064, 3000362258, 3000362671, 3000362933, 3000363162, 3000363947, 3000364082, 3000364309, 3000364520, 3000365379, 3000365391, 3000366446, 3000366831, 3000367160, 3000367439, 3000367542, 3000367852, 3000368165, 3000368658, 3000369005, 3000369122, 3000369645, 3000370069, 3000370290, 3000372257, 3000375534, 3000375776, 3000376132, 3000376388, 3000376542, 3000376883, 3000376883, 3000377320, 3000377699, 3000378079, 3000378654, 3000379282, 3000379691, 3000380264, 3000380475, 3000380671, 3000381287, 3000381620, 3000382054, 3000383367, 3000383779, 3000384088, 3000388588.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94700).

Sources and updates

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