A recall has been issued for the Medtronic Rashkind balloon septostomy catheter. 142 of the devices are covered under the federal recall action and were distributed throughout the United States between May 2018 and August 2020.
According to the FDA, the recall was issued because “quality issues…may lead to the device breaking, separating or failing during use.” The agency goes on to say that “if this occurs, use of the affected product may cause serious adverse health consequences such as damage to blood vessels – vascular injury – and death.” Interestingly, this is not the first action taken against Medtronic over the device. The FDA said that Medtronic had completely stopped producing and selling the Rashkind catheter because of reasons “unrelated to this recall.”
The catheter has indeed already caused at least one death as well as two additional non-fatal injuries. As a result, the recall affecting the Rashkind balloon catheter is a Class I recall which is the agency’s most serious action and is reserved for products whose continued use could cause serious injury or death.
The recall is far from the first for Medtronic and isn’t even the device manufacturer’s first Class I recall. Previous recalls issued against Medtronic devices include a Class I recall for over 320,000 faulty insulin pumps, a 2016 recall for a line of heart pumps, and a 2015 recall for certain batches of neonatal and pediatric tracheostomy tubes. The company has also found itself in hot water over allegations that it used FDA reporting loopholes to conceal injuries caused by its products and may have paid doctors to promote a drug it produced for bone grafts in a way not in alignment with how it was approved.
Medtronic has reached out to its customer database and requested the return of the catheters affected by the latest recall.