Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise
Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involves a sterile medical device where the hazard is a potential loss of sterility (risk of infection). As no specific injuries or illnesses are reported in the source text, this fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atricure Inc is recalling 19,190 units of the CryoICE cryogenic probe for cardiac ablation surgery. The recall is due to packaging defects that may have compromised the sterility of the devices. The CryoICE probe is a sterile, single-use device intended for the cryosurgical treatment of cardiac arrhythmias.
The recall was initiated because mishandling of the product during the packaging process could have inadvertently damaged the sterile barrier. The affected product was distributed worldwide, including in the United States, Canada, and numerous other countries, as well as to 17 government consignees.
Healthcare providers and consumers should check their inventory for the specific batch numbers listed in the official recall notice. If the product is found, it should be stopped from use and returned to Atricure Inc or the distributor for credit or replacement.
The recalled product
- Product
- Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac…
- Manufacturer
- Atricure Inc
- Affected units
- 19,190
Distribution
Distributed nationwide across the United States.
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