Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 30, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Cardiovascular, LLC recalled The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunc… - a moderate-severity action.
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunc… was recalled by Maquet Cardiovascular, LLC in April 30, 2025. Reason: There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the cer…. Check the official notice for the remedy. Verify recall #Z-1622-2025 with the FDA Devices before acting.
The recall
Maquet Cardiovascular, LLC issued this moderate-severity FDA Devices recall-There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the cer….
- Moderate
- severity level
- 22K units
- affected scope
- Class II
- classification
- April 30, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1622-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1622-2025) was formally reported on April 30, 2025, with the manufacturer initiating the action on March 20, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Maquet Cardiovascular, LLC is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 22,244 units.
The documented reason for this recall is: There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while i… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand.. 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
22,244 units
Related Recalls
6
3 from same agency
Product description
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable.
Reason for recall
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1622-2025 |
| Date reported | April 30, 2025 |
| Date initiated | March 20, 2025 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Firm location | Wayne, NJ |
| Affected scope | 22,244 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand. |
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-1622-2025) 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? ▼
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable.. Recalled by Maquet Cardiovascular, LLC. Units affected: 22,244 units.
Why was this product recalled? ▼
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1622-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1622-2025) 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 April 30, 2025. 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.