The Recall Desk
HighFDA (Devices)·Z-2337-2024·Announced 2024-07-17

Endoscopic Vessel Harvesting System Recalled for Altered Component Spacing

Maquet Cardiovascular is recalling 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to reports of C-Ring wire straightening and altered spacing between components. No adverse events have been reported.

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: This FDA Class II device recall involves 27 reported complaints of a mechanical defect (C-Ring wire straightening and altered component spacing) that represents a risk of harm in a surgical device. However, no adverse events or injuries have been reported to date, placing this at the High severity level per the rubric criterion for risk-of-harm products without reported injuries.

Plain-English summary

Maquet Cardiovascular, LLC is recalling approximately 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to a mechanical issue. The system is used in surgical settings for endoscopic vessel harvesting in conjunction with a 7 mm Extended Length Endoscope, featuring a harvesting cannula with four lumens that house the endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches.

The recall was initiated due to reports that the C-Ring wire was straightened due to insufficient bend radius, and the distance between the C-Ring and Harvesting Tool was closer than normal. Between March 22, 2024, and April 30, 2024, the manufacturer received 27 complaints related to the VH-3500 and VH-4000 models regarding these issues. No adverse events have been reported to date in direct association with this issue.

The affected devices were distributed nationwide and internationally. Healthcare facilities should verify whether they have affected devices by checking their lot numbers and contact Maquet Cardiovascular, LLC for further instructions. Affected lot numbers are: 3000371260, 3000378288, 3000362934, 3000371798, 3000378554, 3000372477, 3000378950, 3000376542, 3000380314, 3000377320, 3000380847.

The recalled product

Product
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems 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 — Surgical / Endoscopic
Hazard
  • mechanical-defect
  • design-defect

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 (1)

  • UDI-DI: 00607567700345 Lot Numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category