Recall: Oscor Temporary Bipolar Pacing Leads
On 2018-09-27, the FDA announced that Oscor is conducting a recall on Temporary Bipolar Pacing Leads due to a possible defect. The recalled products were sold under the brand name(s) Oscor during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 1 medical devices recalls due to potential defect, including resuscitator bags, infant/child reduced energy defibrillation electrodes and more. Additionally, there have been 2 drug and medical device recalls due to other health hazards as well as 65 food recalls.
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Phone: (727) 937-2511
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Temporary Bipolar Pacing Leads
Brand Name(s): Oscor
Reason for Recall: Connector cap housing may slide and potentially expose the connection wire
Official Recall Date: 2018-09-27
Additional information provided by the FDA.gov:
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. 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 separates during use. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.