Medtronic ENT Instrument Set Recalled for Verification Failure
Medtronic is recalling 13 reusable ENT instrument sets because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
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, and the hazard involves a failure to pass pre-use verification without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 13 kits of the Medtronic Instrument Set EM ENT (Ref. #9733452 and #9733452-G02). These reusable, prescription-only kits contain straight and curved suction devices intended for use with the StealthStation AxiEM surgical navigation system. The affected products were distributed nationwide in the United States and internationally to Canada.
The recall was initiated because the instruments are unable to pass the instrument verification process that is performed prior to the use of each instrument. This verification is a standard safety check required before the devices are used in surgical procedures.
No specific lot numbers are provided for the kits because the outer boxes containing lot information are discarded by customers upon receipt, and the individual devices are stored separately. Healthcare providers and facilities that have received these specific instrument sets should stop using them and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The sucti
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 13
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.
See all 8 products in this recall →Related recalls
Same manufacturer · Medtronic Navigation, Inc.
See all →- HighMedtronic Percutaneous Reference Pins May Not Fit Properly
FDA (Devices) · 2025-02-05
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
Same hazard · verification failure
See all →- HighNon-Invasive Patient Tracker Verification Failure During Image-Guided Surgery
FDA (Devices) · 2023-02-08
- ModerateMedtronic Curved Suction 90 Recalled for Verification Failure
FDA (Devices) · 2017-08-30
- HighMedtronic ENT Navigation Suction Devices Recalled for Verification Failure
FDA (Devices) · 2017-08-30
- HighMedtronic Fusion ENT Instrument Kit Recalled for Verification Failure
FDA (Devices) · 2017-08-30