Oscor is voluntarily recalling a select number of TB temporary bipolar pacing leads with 2mm unshrouded connectors over issues which may expose the connection wire, according to a recently posted FDA alert.
The company said that the connector cap housing on the leads may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables, which can cause an interruption to the pacing system.
Oscor said that an analysis of the returned devices indicated that the failure is due to a design change to the pin cap housing.
The company said that over the past six years, it has received reports of four serious injuries attributed to the connector cap malfunction which in turn can lead to an interruption to pacing.
No deaths were reported related to the issue, according to an FDA posting, though the agency warned that risk of possible injuries is possible if the connectors separate during use.
A total of 18 different serial numbers were indicated in the recall, which includes straight, atrial j, 60 degree curved and right heart curved leads. The recall affects leads with sizes between 4 French and 6F, according to the FDA release.
Oscor suggested that patients should continuously monitor the situation if they have leads indicated in the recall, and urged them to contact the company.
