On the heels of Integra LifeSciences initiating the global product removal of a pressure monitor device that was experiencing pressure-reading issues, the U.S. FDA identified one patient death, as well as patient injury, in what the administration has labeled as a Class I recall, the most serious type of recall.
Integra disclosed the immediate global voluntary removal of its CereLink ICP monitors last week. At the time, the company said it initiated the action after receiving customer reports about monitors that gave out-of-range pressure readings. Integra spoke to agencies including the FDA and, while the problem was seen at a low rate at a limited number of sites, decided to remove all CereLink monitors from the field.
The FDA now has provided more information about the recall of 388 devices in the U.S. Integra had received 105 global complaints associated with the recall as of the end of July, according to the agency. The agency’s review of its own records revealed at least 68 Medical Device Reports as of Aug. 24.
The 68 reports include descriptions of patient injury and the one death. The reports in the FDA’s public database include a description of a problem with the CereLink pressure reading that led to a “significant surgical delay” of two to four hours.
Read the full article at MedTech Dive.