FDA has classified Integra LifeSciences' recall of 42,100 cerebrospinal fluid drainage systems as a Class I event.
The Plainsboro Township, New Jersey-based device maker began recalling LimiTorr and MoniTorr devices from the U.S. market last month after receiving complaints about broken stopcocks.
To cut the risk of breakages, Integra is advising users to limit the force they apply to LimiTorr and MoniTorr stopcocks.
Integra's LimiTorr and MoniTorr devices enable healthcare professionals to drain cerebrospinal fluid from ventricles of the brain or the lumbar subarachnoid space to an external bag. The devices feature multiple stopcocks to control the flow of liquid.
In some cases, the LimiTorr transducer mount stopcocks and MoniTorr panel mount stopcocks have broken, creating the possibility that liquid will flow in the wrong direction through the system.
The breakages reached the frequency that Integra identified "a complaint trend," leading it to send an Urgent Medical Device Correction letter to affected customers last month and FDA to post a recall notice this week. The FDA notice is the first time LimiTorr or MoniTorr have been the subject of recall alerts, although the agency reported breakages of the former device in its MedSun Program in 2018.
In the recall notices, FDA reiterates advice Integra shared in its urgent letter last month. Customers can continue to use the devices but should take certain precautions, many of which boil down to not applying excessive force to the stopcock.
The recall comes at a time when the quality of some of Integra's products is under scrutiny. In March, FDA hit an Integra manufacturing facility with a warning letter, revealed in a company SEC filing. The Boston facility makes extracellular bovine matrix products, meaning its activities are unrelated to the LimiTorr and MoniTorr recalls.
FDA did not ask Integra to recall the bovine matrix products but the company has recently issued a slew of recall notices about some of its other devices. According to FDA's medical device recalls database, so far this year the agency has issued 29 recall notices about Integra LifeSciences products, compared to eight notices tied to the company across all of 2018 and three total in 2017.
The surge in the number of recall notices stems from problems with a range of total ankle prosthesis products. FDA issued 26 Class II recall notices related to ankle devices last month after learning Integra had listed an incorrect metallic coating material symbol on the labels of multiple products.