Z-0888-06

XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with...

Name: Z-0888-06 XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with...
Creator: Rita Medical Systems, Inc.
Published: 2006-05-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-02 / Terminated / root cause: labeling and UDI

FDA source

Rita Medical Systems, Inc. began a recall of XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm... on 2006-05-02. The reason FDA records is "Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0888-06
Status: Terminated
Initiated: 2006-05-02
Posted: 2006-05-31
Terminated: 2008-02-05
Recalling firm: Boston Scientific Corporation
Product: XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.
Quantity in commerce: 19 units
Distribution: AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
Product codes and lots: Catalog number: 700-103027, Lot number 25952

Product code GEI

K010060Class IIRita Starburst Xli Electrosurgical DeviceRita Medical Systems / cleared 2001-01-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)