Maquet Cardiovascular, LLC medical device recall: VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 95908
- Recall initiated
- Dec 9, 2024
- Classified by FDA
- Jan 3, 2025
- Posted in Enforcement Report
- Jan 15, 2025
- Recalling firm
- Maquet Cardiovascular, LLC
- Firm location
- Wayne, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 9, 2024. FDA classified it 25 days later, on Jan 3, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore,… Maquet Cardiovascular, LLC has 32 recalls in our records.
Recalled products (2)
Z-0711-2025 Class I Ongoing
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Codes / lots: Model Number: VH-4000. UDI-DI: 00607567700406. All unexpired Lots.
Quantity: 418,076 units (326,608 US, 91,468 OUS)
Z-0712-2025 Class I Ongoing
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Codes / lots: Model Number: VH-4001. UDI-DI: 00607567700451. All unexpired Lots.
Quantity: 11,101 units US
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 95908
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.