Dive Brief:
- Centerline Biomedical has recalled guidewires used in vascular procedures over a fault that could cause serious injury or death, the Food and Drug Administration said Friday.
- The company has asked customers to return devices from the affected lots because the coating can come off during the procedure and be left inside the patient.
- No customers have reported serious injuries or deaths associated with the fault. The potential for serious harm led the FDA to publish a Class I recall notice.
Dive Insight:
Healthcare professionals use Centerline’s IOPS Guidewire ATW-2 in the placement of catheters. The wire has sensors that connect to an intraoperative positioning system to help users navigate through vessels and place catheters in target locations. A computer shows the location of the sensor-enabled wire on a map of the patient’s vascular system.
Centerline issued an urgent medical device recall notice in April. The notice explained that the guidewire may delaminate during use. Delaminated coating could be left inside the patient after the procedure, the FDA said. The retention of part of the device in the patient could result in extended or additional surgical procedures, creating a risk of serious injury or death.
The company has mitigated the risk by removing affected devices from the market. The FDA said there are 80 units in commerce in eight states.
The FDA awarded 510(k) clearance to Centerline’s positioning system in 2019, based on a comparison to a predicate device made by Abbott’s St. Jude Medical. Centerline received FDA clearance for an updated version of the system in March. The Class I recall is the first entry for Centerline in the FDA’s database of devices that have been removed from the market or corrected because of faults.
Companies including Abbott, Baxter, Boston Scientific, Edwards Lifesciences, GE Healthcare and Siemens Medical Solutions have recalled products in the same regulatory category as Centerline’s system. Most of the other recalls were Class II, indicating a risk of temporary or medically reversible harm or a remote risk of serious harm.
