CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled

Maquet Cardiovascular is recalling Vasoview Hemopro 2 Endoscopic Vessel Harvesting System, distributed nationwide in the US. The recall was initiated on 6 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00607567700406; Lot Numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, 3000263925

Quantity recalled2300 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1336-2023
FDA event ID: 91764
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 6 Mar 2023
FDA classified: 4 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

6 Mar 2023	Recall initiated by company
4 Apr 2023	Classified by FDA	+29 days
12 Apr 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some batches of product were not sterilized to their minimum sterilization specification.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Brazil, China.

Nationwide

Questions about this recall

Why was it recalled?

Some batches of product were not sterilized to their minimum sterilization specification.

Which lots are affected?

UDI-DI: 00607567700406; Lot Numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, 3000263925

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Brazil, China.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 91764

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023	CLASS II	Vasoview Hemopro, Ous, Endoscopic Vessel Harvesting System recalled	Maquet Cardiovascular	Sterility	Nationwide
12 Apr 2023	CLASS II	Vasoview Hemopro Endoscopic Vessel Harvesting System recalled	Maquet Cardiovascular	Sterility	Nationwide

More recalls from Maquet Cardiovascular

All 252

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled	Maquet Cardiovascular	Sterility	Nationwide
1 Oct 2025Device	CLASS II	Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recalled	Maquet Cardiovascular	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Heartstring III Proximal Seal System Intravascular recalled	Maquet Cardiovascular	Packaging Defects	Nationwide
24 Sep 2025Device	CLASS II	Heartstring III Proximal Seal System Intravascular recalled	Maquet Cardiovascular	Packaging Defects	Nationwide
24 Sep 2025Device	CLASS II	Heartstring III Proximal Seal System recalled by Maquet Cardiovascular	Maquet Cardiovascular	Packaging Defects	Nationwide

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