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Class I Medical Device Recall: St. Jude Medical 6 French Engage? Introducer Devices

Posted Aug 12 2010 9:00pm

Recall Class: Class I

Date Recall Initiated: June 28, 2010
Product(s): Certain batches of the 6 Fr. Engage™ Introducer produced between April 27 and June 03, 2010. Affects approximately 5,120 devices.
Affected products and batch numbers:
  • 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 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.
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, product, and advised Sales Representatives to visit the affected accounts and perform the assigned tasks.
Reason for Recall: The Company identified that some devices in the affected 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, a potentially life threatening episode of bleeding could occur.
Use: The Engage™ Introducer is used to implant catheters and electrodes into blood vessels during surgery and helps to prevent blood loss.
Recalling Firm:          St. Jude Medical, Inc. Cardiovascular Division
                              14901 Deveau Place
                              Minnetonka, Minnesota 55345
Public Contact:         
St. Jude Medical Cardiology Customer Service at or call 1-952-933-4700, or 1-888-864-7444
FDA District: Minneapolis
FDA Comments:
The company is advising customers to discontinue use of the product.

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.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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