Z-0753-2007

RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems...

Name: Z-0753-2007 RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems...
Creator: Rita Medical Systems, Inc.
Published: 2007-04-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-04-03 / Terminated / root cause: packaging

FDA source

Rita Medical Systems, Inc. began a recall of RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816 on 2007-04-03. The reason FDA records is "The product may have a cracked tray which can compromise the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0753-2007
Status: Terminated
Initiated: 2007-04-03
Posted: 2007-04-19
Terminated: 2010-01-20
Recalling firm: Boston Scientific Corporation
Product: RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The product may have a cracked tray which can compromise the sterility of the product.
Root cause tag: packaging
FDA root cause: Other
Action: Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.
Quantity in commerce: 751 devices
Distribution: Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
Product codes and lots: Product number: 700-101493, Lot number: 22442, 25551, 26583, 26937, 27439, 27807 & 29778 and Product number: 700-101493J (Japanese distribution), Lot number: 25599, 25640, 25641, 25642, 25982, 26718, 26719, 26805, 26806, 27045, 27177, 27716, 27717, 27808, 27809, 27941, 27959, 27960, 27975, 27976, 27977, 28436, 28437, 28438, 28518, 28519, 28520, 28521, 28522, 28523, 28524, 28558, 28582, 28583 & 28584

Product code GEI

K983871Class IIRita Model 70 Electrosurgical ProbeRita Medical Systems / cleared 1998-12-01

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)