Recently, the U.S Food and Drug Administration issued multiple advisories relating to catheters, which are medical devices used to drain blood clots or body fluids, among other functions.
Some brands of catheters have been in the news and recalled by manufacturers based on FDA advice after patients have died or reported severe injury due to catheter use.
The latest recalls happened in December 2020, with Penumbra recalling its Jet 7 Xtra Flex catheter, which was used in stroke patients.
Catheters Cause Serious Injury
Defective catheters have caused severe injury, including
- Arterial rupture
- Vessel damage
- Cerebral infraction
As many as 14 deaths were reportedly linked to the Penumbra Jet 7 Xtra Flex catheter. Blood vessel damage, hemorrhaging, and strokes were also reported in patients.
This catheter was used to treat patients with acute ischemic stroke by removing blood clots. The distal tip of the catheter was reportedly weak and easily damaged. Medical reports including descriptions of “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.”
It created a risk to patients when pressure was applied or during contrast injection, where a contrast media is injected into the body for MRI scans.
The FDA asked for the product to be recalled after a fourteenth death was reported in October 2020. No other deaths have since been reported, according to the company’s CEO.
The company was reportedly worried about taking a market hit and its stock price dove by 7.3 percent the day after the announcement. Projections show that the U.S. stroke market will grow to $1 billion in the U.S. and at least $2 billion worldwide.
Thus, there is a lot of incentive for catheter manufacturing companies to place profits above people, and to delay recall of defective products until it is no longer avoidable.
Heart Catheters Also Recalled
In November 2020, the FDA also recalled a heart catheter manufactured by Medtronic PLC which was responsible for causing the death of one patient and injury to two others.
The catheter model was the Rashkind balloon septostomy catheter. Defects in the device reportedly caused it to break, separate, or fail during use. This in turn could cause serious health consequences including damage to blood vessels, vascular injury, and death.
The catheter had been on shelves from May 2018 to August 2020. The FDA classified this recall as a Class 1 recall, which indicates the severity of the issue.
These balloon catheters are generally used to enlarge existing atrial septal defects in the heart to treat those with cyanotic congenital heart defects.
Medtronic had already stopped manufacturing and selling this catheter model even before the recall.
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We Can Help
Medical devices are manufactured to help patients and make their treatment or healing process easier. It is the duty of manufacturers to ensure that these devices don’t malfunction and cause injury, further worsening the health of many patients.
If you’re injured due to any product, you should report it to the appropriate consumer complaint authority at the earliest, after receiving medical care. In this case, all complaints about quality and injuries should be reported to the FDA’s MedWatch safety information and adverse event reporting program.
After reporting the product, you should reach out to a lawyer who specialized in product lability and defective medical devices to discuss your legal options. Pintas & Mullins has a network of skilled personal injury lawyers nationwide, who have dealt with cases involving a range of recalled products and related injuries.
If you or a loved one have suffered due to a defective catheter, you are entitled to justice and compensation for your injury. Contact us today for a free consultation. We don’t charge a penny until you receive a settlement or compensation.