Hill-Rom, which produces the Monarch Airway Clearance System for patients with cystic fibrosis (CF) and other diseases, has put its product on a “temporary shipping hold” as it scrambles to affix labels to 60 of the devices.
According to a Class 2 recall notice posted by the U.S. Food and Drug Administration (FDA), “electromagnetic interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators, as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.”
The mislabeled vests — which are manufactured in Singapore — had already been shipped to customers in 24 states and Canada. Two product numbers are affected: PMACS1NA, which has Bluetooth capability only, and PMACS1WI, which has WiFi capability.
Company representatives are now contacting patients with the devices, a spokesperson said. Serial numbers for the 60 vests are listed on the FDA notice.
Howard Karesh, Hill-Rom’s vice president of corporate communications, said the company is now waiting for an “all-clear” from the FDA.
“This is not a matter of product quality. We are continuing to manufacture and build inventory,” Karesh told Cystic Fibrosis News Today by phone from Chicago. “We have a lot of confidence in the efficacy of this product and just how life-changing it’ll be for those with cystic fibrosis and other respiratory diseases.”
Karesh added: “We are continuing to work with the FDA to update labeling requirements, and addressing what I believe are some potential contraindications. We are nearing the end of that process and we’re hoping to begin shipping product again in the first half of 2018.”
Another Hill-Rom official called it a “field corrective action,” explaining that “the device has magnets on the inside, and magnetic fields can interact with implants. There’s nothing wrong with the devices. We just need to label them appropriately, as per FDA guidance.”
A Class 2 recall notice covers “products that might cause a temporary health problem, or pose only a slight threat of a serious nature,” according to the FDA. A Class 3 recall specifically refers to products with labeling law violations; why this recall is Class 2 was not clear. Class 1 is reserved for “dangerous or defective products” by the FDA.
Karesh declined to say how many Monarch vests have already been produced or are waiting to be shipped out, although he did say it was “hundreds, at a minimum.”
Upon Monarch’s introduction in April 2017, Hill-Rom praised the new vest as a breakthrough: it was the company’s first portable device using a rechargeable battery instead of a generator. The Bluetooth-enabled devices weigh about 13 pounds and come with a portable carrying case, giving its users mobility while at home or traveling.