Medtronic AxiEM ENT Suction Kits Recalled for Verification Failure
Medtronic is recalling eight AxiEM ENT suction kits because the instruments fail mandatory pre-use verification tests.
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 medical device that fails mandatory pre-use safety verification, creating a risk of harm during surgery, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is recalling eight kits of the Medtronic Set Supplemental INS AxiEM ENT (Ref. 9734378). These reusable, prescription-only kits contain small straight suction devices (Ref. 9734308) used with the StealthStation AxiEM surgical navigation system for ENT procedures.
The recall was initiated because the instruments are unable to pass instrument verification, a safety check performed prior to the use of each instrument. The distribution of these kits was worldwide, including nationwide in the United States and in Canada.
Because the outer box containing the lot number is typically discarded by customers upon receipt, no specific kit lot number is provided. Customers should identify the affected devices by their individual device labels and contact Medtronic for instructions on how to proceed.
The recalled product
- Product
- Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are…
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 8
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 (1)
- no kit lot number is being provided.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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