Almost two months ago, Getinge and Maquet Cardiovascular issued a Class 1 recall for the VasoView HemoPro Endoscopic Vessel Harvesting System. According to the FDA, the recall involved two models and multiple lots.
The company announced the recall on September 20th, issuing an Urgent Medical Device Removal letter to all impacted parties. The recall applies to both the VasoView HemoPro 1 (UDI # 00607567700413/VH-3000-W) and the VasoView HemoPro 1.5 (UDI # 00601551101250/VH-3500). Only three lots of the HemoPro 1 are included in the recall, while 110 serial numbers are listed in the recall of the HemoPro 1.5. The FDA has provided a complete list of impacted serial numbers here.
Healthcare providers use the VasoView HemoPro Endoscopic Vessel Harvesting System to obtain healthy blood vessels that can be grafted into another location of the body. Such procedures are particularly common for coronary bypass surgery and other arterial bypass procedures.
Getinge and Maquet Cardiovascular announced the recall after receiving 17 reports of injury caused by the VasoView HemoPro devices. More specifically, the company pointed to the risk of silicone detachment from the harvesting tool during a procedure. If and when silicone material becomes detached during a procedure, the tool becomes dysfunctional and, more importantly, silicone material can be transferred into a patient’s blood system. When this happens, the patient is at risk for a blockage or embolism caused by the foreign material. While the company has not received reports of fatalities, death is a possible outcome in untreated clots and embolisms.
The company advised all hospitals and health care facilities to remove the affected devices from use and to notify all potential users of the recall. Facilities can contact the company for guidance on returning unused devices for a refund. Along with the Urgent Medical Device Removal letter, Getinge and Maquet Cardiovascular sent a Medical Device Removal Response Form, which they asked health care facilities to return for tracking purposes. Customers can return this form by email to Hemopro-peelinq-detachedsilicone2024.act@getinge.com or via fax to 1-866-594-8101.
Anyone with questions or concerns about the recall can reach Customer Support for Getinge and Maquet Cardiovascular at 1-888-880-2874.
Patients and health care providers can report any new adverse health events related to use of the VasoView HemoPro Endoscopic Vessel Harvesting System through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of the VasoView HemoPro Endoscopic Vessel Harvesting System, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.