Medtronic Recalls Covidien Emprint Percutaneous Antenna Due to Generator Shutdown Risk
Medtronic is voluntarily recalling specific lots of the Covidien Emprint Percutaneous Antenna because the generator may shut down during high-temperature measurements.
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 is classified as FDA Class II, and the hazard involves a potential device malfunction (generator shutdown) during a medical procedure where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic is voluntarily recalling specific item codes and production lots of the Covidien Emprint Percutaneous Antenna with Thermosphere Technology. The affected products include Short, Standard, and Long Percutaneous Antennas with model numbers CA15L1, CA20L1, and CA30L1. The recall involves 4,920 units that were distributed worldwide, including US nationwide and to VA/government/military consignees.
The recall is being conducted due to the potential for the generator to shut down in the presence of high temperature measurements in the Emprint Percutaneous Antenna. The product is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. It is not intended for use in cardiac procedures.
The agency classification for this recall is Class II. Users should stop using the affected devices and contact Medtronic or their supplier for further instructions regarding the recall.
The recalled product
- Product
- Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with…
- Category
- Medical Device — Ablation System
- Affected units
- 4,920
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 (2)
- Model Numbers: CA15L1
- CA20L1 and CA30L1
Distribution
Distributed nationwide across the United States.
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