Summary
The FDA issued a Class II for Cardioblate CryoFlex Surgical Ablation Console by Medtronic Perfusion Systems. Reason: There is potential for intermittent electrical connectivity between the console and probe..
Details
Source
Device Recall
External ID
Z-0273-2022
Action Date
2021-12-01
Status
Ongoing
Category
device
Product Description
Cardioblate CryoFlex Surgical Ablation Console
Lot/Code Info: 1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)
Quantity Affected: 7 devices
Reason for Recall
There is potential for intermittent electrical connectivity between the console and probe.
Distribution
Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-27
Company
Brooklyn Park, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Perfusion Systems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Perfusion Systems have FDA actions?
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0273-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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