The Food and Drug Administration (FDA), the federal agency that monitors the use of medically related devices, has recalled heart devices made by a Johnson & Johnson subsidiary because of a faulty valve. The malfunctioning devices were made and distributed between January 1 and May 5, 2017.
The heart device, called the Agilis Steerable Introducer Sheath, is subject to a Class I recall, which is the strictest type of recall and is issued in conditions where the use of a faulty device may cause severe injury or death. The Johnson & Johnson subsidiary that manufactured the product, Sterilmed, is headquartered in Plymouth, Maine.
Heart Device Defective Design
The valve on the Agilis Steerable Introducer Sheath prevents blood from flowing back through it. The device is used to place and position cardiovascular catheters in the heart.
The sheath features a hemostatic valve that is designed to block blood from flowing back through it. However, in more than 100 of the devices, the seal was faulty and was manufactured either with too much or too little glue that makes them unusable.
According to the FDA, “Improper seals can allow the blood to leak through the hub, causing the cap to fall off during the procedure or can create a difference in pressure that allow air into the circulatory system causing an air embolism.”
Sterilmed claimed that it had initiated a recall of the device in June, and that the issue had been resolved.
FDA Warning on Defective Heart Devices
The FDA provided additional information on the product including:
- Produce codes: PNE
- Model and lot numbers: STJ408309, STJ408310, STJG408324
- Number of affected devices: 112
The FDA cautioned medical professionals to immediately check their inventory to ascertain whether they have this device. Moreover, they are advised not to use it, but rather return them unused to Sterilmed. It also suggests that medical professionals carefully monitor patients who received the Sterilmed Reprocessed Agilis Steerable Introducer Sheath.
The FDA also advised both patients who received the sheath and healthcare professionals who monitor the condition of these patients to report any adverse occurrences or side effects related to the use of the product to the FDA MedWatch Safety Information and Adverse Event Reporting Program.
If you, a loved one or someone you know received a Sterilmed Reprocessed Agilis Steerable Introducer Sheath and suffered an adverse event or serious side effect, you may be eligible to file a lawsuit. Contact the Eichholz Law Firm today for a free, no obligation consultation to find out if you have a case. Our attorneys are very knowledgeable in these types of product liability lawsuits and can help you find medical assistance and guide you through the process.