Vasoview HemoproRecalls & reported problems across all models
Maquet Cardiovascular LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Vasoview Hemopro model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 646
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls
- 6
We found 2 models of Vasoview Hemopro by Maquet Cardiovascular LLC in the FDA's device registry (GUDID). Together they are named in 646 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2018 and Sep 27, 2024 — classified as 88 injuries, 558 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (152 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Vasoview Hemopro recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 20, 2024Open, Classified
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
Z-0092-2025 · Root cause: Device Design · Recall details · FDA record ↗
- May 31, 2024Open, Classified
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
Z-2337-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 17, 2024Open, Classified
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Z-2176-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
Z-0724-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
- Mar 6, 2023Open, Classified
Some batches of product were not sterilized to their minimum sterilization specification.
Z-1337-2023 · Root cause: Process control · Recall details · FDA record ↗
- Mar 6, 2023Open, Classified
Some batches of product were not sterilized to their minimum sterilization specification.
Z-1335-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Vasoview Hemopro problems
Device problems
- Peeled/Delaminated152
- Fitting Problem106
- Material Twisted/Bent95
- Break59
- Mechanical Problem56
- Failure to Deliver Energy38
- No Apparent Adverse Event26
- Electrical /Electronic Property Problem25
Patient problems
- No Clinical Signs, Symptoms or Conditions505
- No Consequences Or Impact To Patient80
- Insufficient Information37
- Foreign Body In Patient28
- No Patient Involvement14
- No Known Impact Or Consequence To Patient10
- Hemorrhage/Blood Loss/Bleeding8
- Hematoma4
Vasoview Hemopro models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vasoview Hemopro VH-3500Electrosurgical, Cutting & Coagulation & Accessories4 recalls618 reports
- Vasoview Hemopro VH-3000Electrosurgical, Cutting & Coagulation & Accessories3 recalls28 reports
Recent Vasoview Hemopro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 27, 2024Peeled/Delaminated; Peeled/Delaminated
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW HEMPRO VH-3500 TOTAL SILICON BOOT SLIPPED OFF THE JAWS ON THE NON-WIRE SIDE. A PIECE FELL INTO THE PATIENT AND WAS RETRIEVED BY THE JAWS OF THE CAUTERY TOOL. NO ADDITIONAL INCISIONS. POWER WAS SET TO 3. HARVESTER WAS ABLE TO GRAB THE SILICON PIECE OUT OF THE LEG. THERE WAS NO BURN ON THE VEIN OR ANY DAMAGE DONE TO THE VEIN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. MINIMAL DELAY LESS THAN 5 MINS. PT IS DOING FINE TODAY WITH NORMAL ICU STAY SINCE SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 20320680 ↗MalfunctionSep 25, 2024Peeled/Delaminated; Peeled/Delaminated
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW HEMOPRO VH-3500 JAWS CRACKED BUT REMAINED INTACT AND DID NOT DISLODGE. THE POWER WAS SET TO 3. NOTHING WAS LEFT IN PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM. PER PHOTO PROVIDED BY THE COMPLAINANT, IT IS OBSERVED A PIECE OF THE SILICONE IS BROKEN OFF FROM THE JAWS OF THE DEVICE. THERE IS EVIDENCE OF BLOOD OBSERVED ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301270 ↗MalfunctionSep 11, 2024Break; Break
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 HAD A BROKEN TIP. A NEW DEVICE WAS USED TO COMPETE THE PROCEDURE. THERE WAS NO DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20191181 ↗InjurySep 9, 2024Peeled/Delaminated; Peeled/Delaminated
MalfunctionAug 27, 2024Break; Break
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASO VIEW HEMPRO VH-3500 INNER PORTION OF THE RUBBER CAP BROKE OFF ON THE TROCAR OF THE BTT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076636 ↗MalfunctionAug 27, 2024Peeled/Delaminated; Peeled/Delaminated
MalfunctionAug 26, 2024Mechanical Problem; Mechanical Problem
THE HOSPITAL REPORTED THAT VASOVIEWHEMPRO VH-3500 JAWS LOCKED UP. THERE WAS NO PATIENT INVOLVEMENT. PHOTOS PROVIDED BY COMPLAINANT SHOW THE JAWS OF THE DEVICE IN AN OPEN POSITION WITH EVIDENCE OF USE AS THE METAL WIRE LOOKED SLIGHTLY BLACKENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20070731 ↗MalfunctionAug 23, 2024Peeled/Delaminated; Peeled/Delaminated
THE HOSPITAL REPORTED THAT DURING SEVERAL CASES, VASOVIEWHEMPRO VH-3500 SILICON COATING OF THE JAWS APPEARED TO HEAT UP AND BEGIN TO PEEL AND COME LOOSE. HARVESTER TAKES OUT THE JAWS AND REMOVES THE PIECE THAT HAS COME LOOSE OR BEGUN PEELING. THERE HAS BEEN NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050145 ↗MalfunctionAug 22, 2024Device Remains Activated; Device Remains Activated
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 WOULD NOT DEACTIVATE AFTER BURNING A BRANCH. THE POWER WAS SET TO 2.5. HARVESTER DISCONNECTED AND RECONNECTED THE CORD AND TRIED TO BURN ANOTHER BRANCH AND IT WOULD NOT DEACTIVATE AGAIN. DEVICE WAS DISCONNECTED AND REMOVED FROM THE FIELD. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THERE WAS A DELAY TO OPEN A NEW KIT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20035542 ↗MalfunctionAug 22, 2024Improper Flow or Infusion; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 BTT PORT WAS OCCLUDED, AND CO2 WOULD NOT ENTER THE TUNNEL. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20032431 ↗MalfunctionAug 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionAug 21, 2024Material Twisted/Bent; Material Twisted/Bent
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 CAUTERY DEVICE WAS BENT RIGHT OUT OF THE BOX. THERE WAS NO PATIENT INVOLVEMENT. PHOTO PROVIDED BY COMPLAINANT SHOWS THE JAWS WITH THE METAL WIRE BENT AND PARTIALLY SEPARATED. THERE IS NO EVIDENCE OF BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20009693 ↗MalfunctionAug 17, 2024Peeled/Delaminated; Peeled/Delaminated
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 SILICONE TIP OF CUTTING DEVICE WAS PARTLY DETACHED RIGHT OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT. PHOTOS PROVIDED BY THE COMPLAINANT SHOW THE JAWS WITH THE SILICONE PEELING OFF ONE SIDE. THERE IS NO EVIDENCE OF BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19998741 ↗MalfunctionAug 14, 2024Peeled/Delaminated; Peeled/Delaminated
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 PLASTIC TIP ON JAWS PARTIALLY DETACHED FROM THE METAL. NOTHING DETACHED FROM THE JAWS. UPON DISCOVERING THE DEVICE WAS REMOVED. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PROCEDURAL DELAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982957 ↗MalfunctionAug 13, 2024Mechanical Problem; Mechanical Problem
THE HOSPITAL REPORTED THAT VASOVIEWHEMPRO VH-3500 TIPS WERE UNEVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972391 ↗
Other Maquet Cardiovascular LLC products
All Maquet Cardiovascular LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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