Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 18, 2013
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 for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels
Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Cardiovascular, LLC recalled Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour… - a moderate-severity action.
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour… was recalled by Maquet Cardiovascular, LLC in December 18, 2013. Reason: Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" …. Check the official notice for the remedy. Verify recall #Z-0466-2014 with the FDA Devices before acting.
The recall
Maquet Cardiovascular, LLC issued this moderate-severity FDA Devices recall-Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" ….
- Moderate
- severity level
- 12K units
- affected scope
- Class II
- classification
- December 18, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0466-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0466-2014) was formally reported on December 18, 2013, with the manufacturer initiating the action on October 30, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Maquet Cardiovascular, LLC is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 12,259 units.
The documented reason for this recall is: Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1" Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12,259 units
Related Recalls
6
3 from same agency
Product description
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 for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
Reason for recall
Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0466-2014 |
| Date reported | December 18, 2013 |
| Date initiated | October 30, 2013 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Firm location | Wayne, NJ |
| Affected scope | 12,259 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0466-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.. Recalled by Maquet Cardiovascular, LLC. Units affected: 12,259 units.
Why was this product recalled? ▼
Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2013. Severity: Moderate. Recall number: Z-0466-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0466-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 18, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.