Z-0858-2009

RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac...

Name: Z-0858-2009 RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac...
Creator: Boston Scientific Corp
Published: 2008-11-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-11-25 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by... on 2008-11-25. The reason FDA records is "Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery". 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-0858-2009
Status: Terminated
Initiated: 2008-11-25
Posted: 2009-01-14
Terminated: 2011-04-26
Recalling firm: Boston Scientific Corporation
Product: RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400. Indicated for use in cardiac ablation procedures.
Product code: LPB Cardiac Ablation Percutaneous Catheter
Reason for recall: Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall initiated on November 25, 2008. Urgent Company Initiated Medical Device Recall - Immediate Action Required letters, dated 11/26/2008, were sent to consignees via Federal Express and included return and reply forms for consignees to respond. The letters asked that further distribution or use of any foot switch affected by this recall be ceased immediately. Attached to the letter was a document entitled "Instructions for Determining Affected Product," which provided instructions and serial numbers for determining if customers have product affected by this recall. In addition, a document entitled "Recall Instructions" was also attached. Affected product should be segregated and returned to Boston Scientific in accordance to the "Recall Instructions," and the Reply and Verification Tracking Form should be completed and returned. Customers will receive replacement product for all recalled product returned to Boston Scientific. Local Sales Reps should be contacted in regards to any questions customers may have pertaining to this recall.
Quantity in commerce: 322 units
Distribution: Worldwide Distribution --- including USA and countries of France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya.
Product codes and lots: M004 218400, Serial numbers starting in 0430200, 0530100, 0606100, 0610000, 0620200, 0623700, 0626500, 0629900, 0634800, and ending in 001-405.

Product code LPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)