French Engage Introducer Devices. St. Jude Medical has issued an urgent recall for 6 French Engage Introducer devices. The US Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious recall action.
The Engage Introducer is used to implant catheters and electrodes into blood vessels during surgery and helps to prevent blood loss. According to the recall notice, some devices in the recalled batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly.
If either of these were to occur during use
If either of these were to occur during use, a potentially life threatening episode of bleeding could occur.
Batches of the Engage Introducer affected by this recall were produced between April 27 and June 03, 2010. The recall affects approximately 5,120 devices. The affected batch and product numbers are as follows:
• Engage TR Introducer, 6 Fr. – ACT (2.25 mm), 7 cm length, .025″ Max Guide wire, Batch: 3109782
• Engage TR Introducer, 6 Fr. – ACT (2.25 mm), 12 cm length, .025″ Max Guide wire, Batch: 3105838
• Engage TR Introducer, 6 Fr. – ACT (2.25 mm), 25 cm length, .035″ Max Guide wire, Batch: 3107645
• Engage TR Introducer, 6 Fr. – ACT (2.25 mm), 12 cm length, .035″ Max Guide wire, Batches: 3103891, 3110889, 3110892, 3118794, 3123051
• Engage TR Introducer, 6 Fr. – ACT (2.25 mm), 12 cm length, .038″ Max Guide wire, Batches: 3107789, 3107790
St. Jude Medical is advising its customers to discontinue use of this product. The company sent customers an “Urgent Medical Device Recall Notice” letter dated June 24, 2010. The letter was addressed to Cath Lab Manager/ Risk Manager and described the problem and the product involved.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.