Medtronic ENT Navigation Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling six kits of ENT suction devices because they fail required pre-use verification checks.
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 risk-of-harm medical device where the instruments fail required verification, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is recalling six kits of the Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM. These reusable, prescription-only kits contain straight and curved suction devices used with the StealthStation AxiEM surgical navigation system. The devices are intended to have an ENT Instrument Tracker mounted on them to assist in tracking instrument position during surgery.
The recall was initiated because the instruments are not able to pass instrument verification, a check that is performed prior to the use of each instrument. The affected products were distributed nationwide in the United States and internationally to Canada.
Healthcare facilities that have received these kits should stop using the affected suction devices and contact Medtronic Navigation for instructions on how to proceed.
The recalled product
- Product
- Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc.…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 6
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.To be 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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