Z-2180-2010

St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx...

Name: Z-2180-2010 St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx...
Creator: St. Jude Medical Cardiovascular Division
Published: 2010-06-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-06-28 / Terminated / root cause: manufacturing process

FDA source

St. Jude Medical Cardiovascular Division began a recall of St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549 on 2010-06-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2180-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2010-08-12
Terminated: 2011-12-27
Recalling firm: Abbott Medical
Product: St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 5 US, 10 OUS
Distribution: Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
Product codes and lots: Batch in US and OUS: 3107645

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)