Medtronic Curved Suction 90 Recalled for Verification Failure
Medtronic is recalling 75 Curved Suction 90 ENT instruments because they fail required pre-use verification checks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional failure of a safety verification system, which poses a risk of harm but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Medtronic Navigation, Inc. is recalling 75 units of the Medtronic Curved Suction 90 9733451 EM ENT reusable surgical instrument. These devices are used with the StealthStation AxiEM surgical navigation system for ENT procedures. The recall covers specific lot numbers distributed nationwide in the US and internationally to Canada.
The recall was initiated because the instruments are unable to pass instrument verification, a safety check that must be performed prior to the use of each instrument. This failure prevents the system from accurately tracking the instrument tip in relation to patient anatomy.
Healthcare providers should stop using the affected instruments immediately. Medtronic is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. 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 used with the StealthStationTM AxiEM surgical navigation system. Th
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 75
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 (10)
- Lot numbers 17030728
- 17022027
- 17021426
- 17013125
- 17012724
- 17011303
- 16122767
- 16122066
- 16112965
- and 16112164
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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