Thousands of products — from ice cream to car steering wheels — get recalled every year. And the FDA has a classification for those recalls, based on the injury risk posed by a defective product. Class I recalls are reserved for the most dangerous of defective products: “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
That’s the type of recall the FDA issued for a heart device made by a Johnson & Johnson subsidiary, claiming to a faulty valve can allow excess blood to leak into the heart or cause embolisms.
Sheaths, Valves, and Seals
According to the FDA, the Agilis Steerable Introducer Sheath is used to insert and position cardiovascular catheters in the heart. The sheath is made by Sterilmed, and places catheters on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart.
The sheath has a hemostatic valve, designed to prevent blood from flowing back through the valve. But the valves on over 100 of the devices had an improper seal, where either too much glue or not enough renders the device unusable. The FDA warns: “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).”
The FDA also provided specific information on the affected devices:
- Name: Sterilmed Reprocessed Agilis Steerable Introducer Sheath
- Product codes: PNE
- Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots
- Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017
- Number of Affected Devices: 112
Medical professionals are advised to immediately examine inventory to determine if they have this product and not use any of the affected products. Instead, they should return any unused product to the company, and continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath.
And patients and healthcare professionals should report any adverse events or side effects related to the use of the product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
If you’ve been injured by a defective heart device, you may want to contact a local attorney.