In September 2024, Maquet Cardiovascular, a subsidiary of Getinge, initiated a recall of its VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting (EVH) Systems due to safety concerns.
The recall was prompted by reports of silicone detaching from the jaws of the harvesting tool during use, leading to device malfunction and the introduction of silicone debris into patients.
This issue has resulted in at least 17 serious injuries, including three cases where the silicone debris could not be retrieved.
The U.S. Food and Drug Administration (FDA) classified this as a Class I recall, indicating a situation where there is a reasonable probability that the use of these products could cause serious adverse health consequences or death.
Healthcare providers are advised to consider alternative devices and to exercise caution when using any EVH systems, inspecting them for signs of damage or silicone peeling prior to use.
Key Points of the Recall:
- Recall Initiation: September 2024 by Maquet Cardiovascular (Getinge subsidiary).
- Affected Devices: VasoView HemoPro 1 and 1.5 EVH Systems.
- Reason for Recall: Silicone detachment from the jaws during use.
- Reported Injuries: 17 serious injuries; silicone debris unretrievable in 3 cases.
- FDA Classification: Class I recall.
- Supply Impact: EVH devices added to FDA’s medical device shortage list.
- Recommendations for Providers: Seek alternative devices; inspect EVH systems for damage or silicone peeling before use.
- Patient Safety Concerns: Potential for procedural delays and conversion to more invasive procedures.
Potential Injuries Caused by Defective EVH Devices
Patients and healthcare providers have reported several injuries linked to the malfunctioning Maquet Cardiovascular EVH devices.
These injuries include:
- Silicone Debris Complications: Silicone fragments introduced into the patient’s body may cause inflammation, foreign body reactions, or long-term complications if not retrieved.
- Infection Risk: Device failure during surgery can increase the likelihood of infections at the surgical site.
- Extended Recovery Times: Conversion to open harvesting procedures due to device failure often leads to increased recovery times and additional scarring.
- Emotional and Financial Stress: Patients and families may face emotional challenges and financial burdens due to additional surgeries or complications.
