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Terminated

Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47

FDA Recall Z-0351-03 · Posted None

Recalling FirmMedtronic Cardiac Surgery Technologies
Recall StatusTerminated
Product Code74
Date Initiated2002-11-11
Date Terminated2004-07-02
Product Quantity148 pens

Reason for Recall

The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.

Firm Action

A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives.

Root Cause

Other

Distribution Pattern

All of the consignees were in foreign countries in Europe, Asia and Latin America.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013392CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880Medtronic Vascular · 2002-01-25

Official Source

View FDA Recall →

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

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