Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
This recall has been terminated (originally issued November 11, 2002).
- Recall Initiated
- November 11, 2002
- Terminated
- July 2, 2004
- Recall Number
- Z-0351-03
- Quantity
- 148 pens
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
All of the consignees were in foreign countries in Europe, Asia and Latin America.
Lot / Code Info
Lot number 2002080004
Root Cause
Other
Action Taken
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.
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