—#189622

Product

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

FDA product code: NEY — System, Ablation, Microwave And Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 516840

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand.

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: No domestic distribution. Foreign distribution to Hong Kong and UK.

Timeline

Recall initiated: 2021-09-29
Terminated: 2025-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.