FDA Recalls St. Jude Medical's 6 French Engage Introducer Device
On June 24, 2010, the FDA issued a class I recall of several St. Jude Medical 6 French Engage Introducer devices because its shaft or hub assembly may break and cause potentially fatal bleeding.
The Introducer device is used to implant catheters and electrodes into blood vessels and helps to prevent blood loss. Included in the recall are several batches of Engage TR Introducer 6 Fr. ACT (2.25 mm) devices:
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7 cm length, .025" Max Guide Wire (batch# 3109782)
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12 cm length, .025" Max Guide Wire (batch# 3105838) 25 cm length, .035" Max Guide Wire (batch# 3107645)
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12 cm length, .035" Max Guide Wire (batches 3103891, 3110889, 3118794, and 3123051)
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12 cm length, .038" Max Guide Wire (batches 3107789 and 3107790)
Recommendations
The recall affects around 5,120 devices produced between April 27 and June 3, 2010. The FDA advises healthcare professionals are advised to cease using the affected devices.
Please view the following for more information and in-depth instructions:
