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| Fuhrman Pleural/Pneumopericardial Drainage Set--Courtesy of Stryker |
The FDA warned of the possibility of Stryker's ($SYK) Fuhrman Pleural/Pneumopericardial Drainage Set breaking in the membrane that surrounds the lung, a potentially fatal complication.
Stryker issued a recall of 34 units of the device in November after receiving two reports of the drainage set's catheter breaking off following insertion in the pleural cavity. Both adverse events required medical intervention. The FDA earlier this month deemed the recall Class I, which occurs when the agency believes that the use of the faulty device may cause serious injury or death.
The FDA says that the device is used to "remove air from the sac (pericardium) surrounding the heart, or to drain air or fluid from thin covering (pleural cavity) that protects the lungs."
Stryker urged customers to discontinue use of the product and return any affected devices. The FDA noted the lot numbers of the recalled devices, which were distributed in 8 states.
The recall was also posted in the FDA's comprehensive database of recalls and their risk classifications (Class I, II or III). But publication of the recall in the more prominent section of the website indicates that the agency wants to highlight the risks by the particular device and ensure the affected devices are returned to the company quickly.
The company just reported that its quarterly net sales grew 3.7% (7% after adjusting for exchange rate fluctuations) year-over-year to $2.7 billion, led by 6.5% sales growth in its neurotechnology and spine unit, as well as 3.3% growth in orthopedics and 3% growth in its medsurg division.
Annual sales grew 2.8% (7% after adjusting for exchange rate fluctuations) to $9.9 billion.
Stryker is pinning its hopes on robotic orthopedic surgery. It sold 31 Mako robots during the quarter and 72 during 2015, an increase of 6.1% for the full year.
- read the FDA's recall notice | here's more from the FDA
- view the recall in the FDA database