Maquet Vasoview Hemopro Endoscopic Vessel Harvesting System Recalled for Overheating
Maquet Cardiovascular is recalling 12,259 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System due to complaints that the device self-activates or overheats.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk of overheating and unintended activation, which poses a risk of harm (burns or tissue damage) to patients, but the source text does not explicitly report 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 12,259 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System (Catalog numbers VH-3000 and VH-3000W). The device is indicated for minimally invasive surgery, specifically for vessel harvesting and tissue dissection in patients undergoing endoscopic surgery for arterial bypass.
The recall was initiated after the manufacturer received an increase in complaints regarding the device "self-activating," "remaining activated," or "overheating." The affected units were distributed worldwide, including the United States, Brazil, the Czech Republic, Denmark, France, Hong Kong, Italy, the Middle East, the Netherlands, Singapore, Switzerland, and the United Kingdom.
Healthcare providers and patients should stop using the affected devices immediately. Maquet Cardiovascular is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery…
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 12,259
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)
- Catalog number VH-3000 (US) Lot numbers 25081686
- 25081595
- 25081460
- 25081204
- 25080939
- 25080744
- 25080418
- 25080351
- 25080264
- 25079982
- 25079913
- 25073724
- 25079449
- 25079363
- 25079086
- 25078931
- 25078713
- 25078463
- 25078291
- 25078104
Distribution
Distributed nationwide across the United States.
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