Medtronic has recalled certain Pipeline Vantage Embolization Devices with Shield Technology due to an increased risk of incomplete wall apposition and braid deformation, which could lead to stroke or death.
The FDA has classified this as the most serious type of recall and involves the removal of unused Pipeline Vantage 027 devices from the market and an update to the instructions for use for Pipeline 021 devices, according to a March 18 news release from the agency.
Medtronic has advised healthcare providers to stop using the affected 027 models and return them. The updated instructions for the 021 devices provide guidance on device selection and deployment techniques to reduce the risk of complications.
Thirteen injuries and four deaths have been associated with the 027 device and four injuries with the 021 device.
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