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

FDA device recall Z-0858-2009 · posted 2009-01-14 · Terminated

Recall details

Recalling firm

Boston Scientific Corp

Reason for recall

Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LPB

Quantity affected

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.

Date initiated

2008-11-25

Date posted

2009-01-14

Date terminated

2011-04-26

Location

San Jose, CA