The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Len
FDA device recall Z-2176-2024 · posted 2024-06-24 · Open, Classified
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- 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.
- Action taken
- 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 VVHemoPro2024.act@getinge.com 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 37,186 units
- 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.
- Date initiated
- 2024-05-17
- Date posted
- 2024-06-24
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASOVIEW HemoPro Endoscopic Vessel Harvesting System (K153194) | Maquet Cardiovascular, LLC | 2016-04-19 |