Medtronic CryoConsole Recalled Due to USB Component Issue
Medtronic is recalling 103 CryoConsole units because a USB memory component issue can result in extended procedure time during cardiac ablation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves a risk of harm (extended procedure time) in a medical device, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling 103 units of the Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K. These devices are used for performing cardiac ablation procedures.
The recall is due to an issue with a USB memory component contained within a subset of the CryoConsoles. This issue can result in extended procedure time. The affected units were distributed worldwide, including in the United States and internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. The agency has classified this as a Class II recall.
The recalled product
- Product
- Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Hazard
- Affected units
- 103
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- serial numbers: 5K0005
- 5K0006
- 5K0007
- 5K0009
- 5K0010
- 5K0011
- 5K0012
- 5K0013
- 5K0014
- 5K0015
- 5K0016
- 5K0017
- 5K0018
- 5K0019
- 5K0020
- 5K0021
- 5K0022
- 5K0023
- 5K0024
- 5K0025
Distribution
Distributed nationwide across the United States.
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