St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF

FDA device recall Z-2179-2010 · posted 2010-08-12 · Terminated

Recall details

Recalling firm

St. Jude Medical Cardiovascular Division

Reason for recall

Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.

Action taken

Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.

Root cause

Process design

Status

Terminated

Product code

DYB

Quantity affected

90 OUS

Distribution

Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.

Date initiated

2010-06-28

Date posted

2010-08-12

Date terminated

2011-12-27

Location

Minnetonka, MN

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