Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Leads (Unshrouded 2 mm Pins Models)
Oscor Inc. has issued a recall of TB – Temporary Bipolar Pacing Leads (Unshrouded 2 mm Pins Models). According to Oscor, during the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. See the recall notice, Picture 1, No. 2 Pin Cap and Cover. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins.
In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system. No deaths were reported; however, the risk for possible injury is a concern if the connectors separate during use.
According to the recall notice, for pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.
Follow the link below to read the recall notice, including a full listing of recalled product and model numbers and product photos.
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