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Atar Extension Cables By Oscor: Recall

Atar Extension Cables by Oscor: Recall - Cable Separating from Connector

ISSUE: During the use of some Atar extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. This event resulted in cable malfunction, causing interruption of the pacing system.

Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. No deaths were reported; however the risk for possible injury is a concern if the cable separates during use. For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required. Ref. Fda.gov.

Recall Oscor Cables Extension Atar

Yeah that is a serious life or death situation and they need to be recalled so the patients can have peace of mind that their heart will still beat as it should.