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Terminated

Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.

FDA Recall Z-1456-05 · Posted 2005-08-31

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGEI
Date Initiated2005-07-15
Date Terminated2007-02-07
Product Quantity115

Reason for Recall

The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.

Firm Action

Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.

Root Cause

Other

Distribution Pattern

Nationwide, Germany, Italy, Netherlands, Spain and Sweden.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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