The Recall Desk
HighFDA (Devices)·Z-1622-2025·Announced 2025-04-30

[pending] The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with t

Pending LLM rewrite. Source: FDA_DEVICE Z-1622-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.

The recalled product

Product
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is 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 cauterizin
Manufacturer
Maquet Cardiovascular, LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. VH-4000 (Hemopro 2)
  • VH-4001 (Hemopro 2 w/ Vasoshield)
  • UDI-DI: 00607567700406 (Hemopro 2)
  • 00607567700451 (Hemopro 2 w/ Vasoshield)
  • Lot/Serial No. 3000436447
  • 3000437191
  • 3000439557
  • 3000439600
  • 3000439623
  • 3000439922
  • 3000440187
  • 3000440220
  • 3000440283
  • 3000440754
  • 3000440957
  • 3000440981
  • 3000440982
  • 3000441144
  • 3000441319
  • 3000441541

Distribution

Distributed nationwide across the United States.

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