Vasoview Hemopro 2 VH-4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,232 adverse event reports that list this exact device (DI 00607567700406), received between Jan 23, 2019 and Sep 29, 2026 — classified as 1 death, 216 injuries, 3,015 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (665 reports).

6 FDA recall records name this device's identifier, 6 still open.

4 other recalls cover devices cleared under the same FDA submission (K101274); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 2, 2026Class IIOpen, Classified

   Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.

   Z-2741-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 20, 2025Class IIOpen, Classified

   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.

   Z-1622-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Dec 9, 2024Class IOpen, Classified

   Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

   Z-0711-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. May 31, 2024Class IIOpen, 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-2338-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. May 17, 2024Class IIOpen, 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-2175-2024 · Root cause: Device Design · Recall details · FDA record ↗

6. Mar 6, 2023Class IIOpen, Classified

   Some batches of product were not sterilized to their minimum sterilization specification.

   Z-1336-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 3,232 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931879 ↗
• MalfunctionSep 29, 2026Material Twisted/Bent

  The hospital reported that during use of the VasoView Hemopro 2, the metal jaw of the cauterization area detached. The equipment was inspected before use. Before inserting the sampling device, the endoscope is inserted into the cannula. As instructed in the user manual, the jaws of the harvesting tool are closed and inserted with the tips pointing upward. There was no resistance when inserting the sampling device into the cannula. No parts of the device have fallen into the sampling tunnel or into the patient's body. New VasoView Hemopro 2 was used to complete the surgery. The procedure was completed without any problems. No health problems were reported for the patients. There was no delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931878 ↗
• MalfunctionSep 28, 2026Insufficient Device Problem Information

  The hospital reported broken tip of the VasoView Hemopro 2 right out of the box. The sterile packaging was intact. It happened before the procedure during set up. No procedure delay. New device was used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914348 ↗
• MalfunctionSep 28, 2026Material Twisted/Bent

  The hospital reported that upon opening VasoView Hemopro 2, it was noted that the rod on the c-clamp was bent. New device was opened and this device was not used, but placed back in box as defective. The issue was discovered prior to use. the sterile packaging was intact. The patient was not in the OR. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912489 ↗
• MalfunctionSep 25, 2026Insufficient Device Problem Information

  The hospital reported that VasoView Hemopro 2 was defective.

  Patient problems: Insufficient Information

  MAUDE report 50897804 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  The hospital reported that there was VasoView Hemopro 2 malfunction. The customer stated that when the harvester acctivated the VasoView Hemopro 2, the T.W. Power Supply would beep but it would not provide power/energy to jaws. Happened during case. A pre-test was not done. The power setting on the Hemopro Power was 3. Patient was in OR. Opened up another VasoView Hemopro 2 to complete case. No patient effects or delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895156 ↗
• MalfunctionSep 25, 2026Intermittent Loss of Power

  The hospital reported that during the second phase of the procedure the VasoView Hemopro 2 experienced the activation of the poly fuse and timed out. All appropriate troubleshooting steps were performed without success. A new kit was opened and functioned accordingly. No patient adverse events.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893955 ↗
• MalfunctionSep 24, 2026Smoking

  The hospital reported that the VasoView Hemopro 2 smoke would not evacuate from the tunnel at the beginning of the vein harvest. Pre-cautery test was not performed. A new VasoView Hemopro 2 was used to successfully complete the procedure. Patient was not injured. No additional time was added to the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882379 ↗
• MalfunctionSep 24, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882377 ↗
• MalfunctionSep 24, 2026Poor Quality Image

  The hospital reported that there were visibility problems during an EVH procedure with a VasoView Hemopro 2. The procedure was successfully completed with the same device. No patient harm occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880263 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  The hospital reported that during an endoscopic vein harvesting procedure, VasoView Hemopro 2 would shut down during dissection. An audible beep was heard from the power supply during activation. Power setting at 3. There was a procedural delay while waiting for a new device. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880261 ↗
• InjurySep 24, 2026Failure to Cut

  The complaint was opened as information was received from Health Canada stating that, during an endoscopic vein harvesting procedure, the VasoView Hemopro 2 was not sealing or cutting properly. Considerable bleeding was noted from the posterior-medial branch of the small saphenous vein in the right thigh; approximate blood loss was 200ml. Leg had to be opened: skin subcutaneous incision 15cm in length made.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 50880185 ↗
• MalfunctionSep 24, 2026Material Twisted/Bent

  The hospital reported separation of the metal wire from the jaws of the bi-sector VasoView Hemopro 2. No patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879227 ↗
• MalfunctionSep 23, 2026Mechanical Problem

  The hospital reported that c ring won't fully retract all the way in VasoView Hemopro 2, so PA was unable to see during use. The issue happened during procedure. No injuries for patient was reported. There was no procedural delay. New device was used to completed surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868563 ↗
• MalfunctionSep 23, 2026Material Twisted/Bent

  The hospital reported that during a CABG the Vasoview Hemopro 2 was used. After harvesting the saphenous vein the surgeon proceeded to harvest the radial artery. Halfway during the transection of the radial artery the proctor noticed that the wire came lose from the cutter. A new device was opened and the procedure was completed successfully. There was no harm to the artery or the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865744 ↗
• MalfunctionSep 23, 2026Intermittent Continuity

  The hospital reported that during the second phase of the procedure the VasoView Hemopro 2 experienced the activation of the poly fuse and timed out. All appropriate troubleshooting steps were performed without success. A new kit was opened and functioned accordingly. No patient adverse events.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864976 ↗
• MalfunctionSep 22, 2026Failure to Cut

  The hospital reported that during an endoscopic vein harvesting procedure, the cautery did not work in VasoView Hemopro 2. Another kit was opened and the procedure was successfully completed. No patient injury. No details on any other troubleshooting methods were provided. There was no procedural delay aside from the few minutes to open a new VH-4000 kit.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852397 ↗
• MalfunctionSep 22, 2026Failure to Cut

  The hospital reported that VasoView Hemopro 2 was not burning. Jaws did not appear to be injured or broken, power cord was changed, and power supply box was on and at 3.5 setting. There was an audible beep and both lights were illuminated. However the power supply box states "Guidant" on it demonstrating the age of the box. Toggle was fully engaged to activate device. Toggle was reactivated and it works for a few seconds then did not work again. Only delay was the time needed to open additional kit. No harm to patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851939 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  The hospital reported that VasoView Hemopro 2 wouldn't burn halfway through the case. The harvester switched out cable, adaptor and power supply and the problem persisted. The surgeon switched out kit and problem was resolved. There was procedural delay of 67 min. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851935 ↗
• MalfunctionSep 21, 2026Break

  The hospital reported that there was an issue with VasoView Hemopro 2 during a case. The clamp was broken during the procedure and the customer was unable to use the device. The issue was noticed after takin the first branch with device. No resistance was noted while inserting the harvesting tool into the cannula. Noting dislodged into the patient¿s leg/arm/tunnel. There was procedure delay. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839317 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem

  The hospital reported that during a CABG a VasoView Hemopro 2 continuously timing out. Power setting at 3. The toggle was fully slid backward to deliver energy to the jaws, and a ¿click¿ was felt to indicate activation of the device. The procedure was completed successfully with a very minor case delay of 2 minutes. A new device was used to complete the procedure. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838992 ↗
• MalfunctionSep 18, 2026Melted; Material Twisted/Bent

  The hospital reported that during an endoscopic vein harvest procedure, the harvester was sealing a large vein branch. After energy activation for several seconds, the time-out feature of the device occurred after approximately 15 seconds. Following this, multiple re-activations of energy, with the jaws closed using the spot cautery, occurred due to bleeding from the tunnel wall. Following control of the bleeding, the harvester noticed the jaws of the cautery device "did not look right". After removal of the device from the patient and further inspection, the silicone coating appeared melted and the wire did not appear in its original state. To avoid any potential problems, this device was removed from the field and a new VasoView Hemopro 2 was opened. Prior to using the new kit, it was inspected and appeared intact. The new device was used to complete the vessel harvest as expected, without complication. The power setting on the power supply was set to "3". A wet-gauze test was not performed prior to using, however the device did successfully seal several branches prior to the above issue. During branch division, there was an audible beeping sound heard. There was no harm or death

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816508 ↗
• MalfunctionSep 18, 2026Electrical /Electronic Property Problem

  The hospital reported that when harvester had completed dissection and was taking branches he did experience the VasoView Hemopro 2 shutting down after some prolonged burning, but the it did not recover at all with rest. The Power Supply was changed out with no effect. At that point, a new HemoPro 2 was opened and that one worked as expected. Power Supplies set at 3. There was an audible beep from the power supply during activation when the difficulty cutting branches occurred. they were unable to determine whether both lights on the power supply were illuminated. The toggle was fully slid backward to deliver energy to the jaws. The HP2 does not have a tactile click to indicate activation. There was a delay due to switching out the components and finally having to open another kit. There was no patient harm or adverse effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815001 ↗
• MalfunctionSep 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794921 ↗
• InjurySep 16, 2026Peeled/Delaminated; Material Twisted/Bent

  The hospital reported that VasoView Hemopro 2 used in CHH had split jaws. It happened on both side¿s, one side completely and the tip looked sharp. The surgeon did three length of vein and was about to finish last length of vein when it happened. Another device was used to complete the case and a redivac drain was inserted. Based on the provided photos the heating wire is twisted/bent and the insulation gap is visible.

  Patient problems: Insufficient Information

  MAUDE report 50794824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101274. One submission often covers many models, so check the product and lot details in each record.

• Z-1577-2025 · Mar 10, 2025 · Open, Classified
  Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
• Z-0712-2025 · Dec 9, 2024 · Open, Classified
  Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvestin
• Z-0995-2023 · Dec 22, 2022 · Open, Classified
  Hemopro 2 with Vasoshield, Model VH-4001
• Z-0466-2014 · Oct 30, 2013 · Terminated
  Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing acce