FDA Device recall Z-2741-2026
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 by Maquet Cardiovascular, citing getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-287….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2741-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-02 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Reason
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Identifiers
| code_info | UDI 00607567700406, Serial/Lot Number 3000547797 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Maquet Cardiovascular
- Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000
FDA Device · Class II · 2025-10-01 · Maquet Cardiovascular - Heartstring III Proximal Seal System
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope
FDA Device · Class II · 2025-04-30 · Maquet Cardiovascular
All Maquet Cardiovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2741-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.