Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Summary
The FDA issued a Class II for Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ab by Covidien Llc. Reason: The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary c.
Details
Source
Device Recall
External ID
Z-0210-2022
Action Date
2021-11-17
Status
Terminated
Category
device
Product Description
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Lot/Code Info: Lot 516840
Quantity Affected: 14 units
Reason for Recall
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
Distribution
No domestic distribution. Foreign distribution to Hong Kong and UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-29
Company
Mansfield, MA
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 102 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 clearances.
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 (Covidien Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien Llc have FDA actions?
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0210-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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