September 28, 2018
FDA: Oscor Inc recalls TB-Temporary Bipolar Pacing Leads
Editor's Note
The Food and Drug Administration (FDA) on September 27 announced the recall by Oscor Inc (Palm Harbor, Florida) of its TB-Temporary Bipolar Pacing Leads, with 2 mm unshrouded connectors.
The recall was initiated because the connector cap housing may slide and expose the connection wire. This may cause the wire to lose connectivity or break during movement of the cables, causing interruption of the pacing system.
For pacing dependent patients, an interruption of pacing could result in serious injury or death.
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