Boston Scientific Korea said that it has started taking corrective measures, such as recalls and repairs, for EMBLEM S-ICD Subcutaneous Electrode Model 3501, its implantable cardioverter defibrillator, due to the risk of the device fracturing.

Boston Scientific Korea has started to take corrective measures for its defibrillator, EMBLEM S-ICD Subcutaneous Electrode Model 3501, due to the device’s fracturing during use. (Boston Scientific)
Boston Scientific Korea has started to take corrective measures for its defibrillator, EMBLEM S-ICD Subcutaneous Electrode Model 3501, due to the device’s fracturing during use. (Boston Scientific)

The move comes after the U.S. Food and Drug Administration issued Class I recall, the most serious type of recall, for the device's increased risk of fractures of the device at a specific point.

Boston Scientific has received 27 reports of the device's electrode body fracturing at a location just distal to the proximal sense ring.

According to the FDA, if the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats from cardiac arrests. While the fracture's event is low as the company puts the cumulative occurrence rate of the fault at 41 months at 0.2 percent, it can lead to severe consequences as the company has received 26 reports of serious injuries and one death related to the device.

"In Korea, the company has notified the situation to hospitals that use the company's device," a Boston Scientific Korea representative said to Korea Biomedical Review. "Also, we are taking additional measures, such as recall or repair, through our sales branches."

Despite the FDA’s classifying the recall as one of its most serious recall measures, the official stressed that it is more of an order to take corrective actions than recall the product.

"The FDA’s recall class 1 only applies to products that may cause serious adverse health effects or deaths," the official said. "In class 1 recall, FDA divides the measure into two types -- a recall or corrective measure -- of a commercially available product. In the case of the EMBLEM S-ICD Subcutaneous Electrode Model 3501, the FDA has ordered a corrective measure.”

The official explained that a corrective measure includes repairing, modification, adjustment, relabeling, or inspection without physical movement of the product. "As it is a corrective measure order and not a recall, manufacturing and distribution of the product will continue," she said.

The FDA has also issued a Class I recall on two more of the company's implantable cardioverter-defibrillator -- S-ICD A209 and MRI S-ICD A219 -- after a manufacturing process of the devices possibly allowing moisture to get inside the defibrillators and cause a short-circuit when they try to deliver high voltage shocks.

Boston Scientific Korea reiterated that the recall order would not affect Korea.

"In the case of a recall, the scope of the recall is determined based on the manufacturing date," the official said. "Although the company sells the product in Korea, the company did not import any of the products manufactured during the specific period that the FDA has ordered a recall on."

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