The Recall Desk
HighFDA (Devices)·Z-1456-2017·Announced 2017-03-22

Maquet Recalls VASOVIEW HEMOPRO VH-3500 Endoscopic Vessel Harvesting System

Maquet Cardiovascular is recalling 4,283 VASOVIEW HEMOPRO VH-3500 units due to reports of intermittent or no power.

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: The recall involves a medical device with a functional failure (power loss) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling 4,283 units of the VASOVIEW HEMOPRO VH-3500 Endoscopic Vessel Harvesting System. The device is designed for use with a 7-mm Endoscope and the VASOVIEW HEMOPRO Power Supply.

The recall was initiated after the manufacturer received several complaints indicating that the device exhibited a failure mode of intermittent or no power. The affected units were distributed nationwide in the United States.

Healthcare providers and consumers should stop using the affected devices and contact Maquet Cardiovascular for further instructions. Specific lot codes for the recalled units are listed in the official recall documentation.

The recalled product

Product
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Affected units
4,283

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 (18)

  • 25126012
  • 25126080
  • 25126250
  • 25126375
  • 25126542
  • 25126659
  • 25128301
  • 25128602
  • 25128820
  • 25128905
  • 25129016
  • 25129155
  • 25129199
  • 25129239
  • 25129286
  • 25129335
  • 25129416
  • 25129513

Distribution

Distributed nationwide across the United States.