Medtronic ENT Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling 277 reusable ENT suction instruments because they fail pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
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 verification, creating a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Navigation, Inc. is recalling 277 units of the Medtronic Straight Suction 9733449 EM ENT reusable instruments. These devices are prescription-only and are used as suction and pointing tools in conjunction with the StealthStation AxiEM surgical navigation system. The AxiEM system tracks the position and orientation of the instrument tip relative to patient anatomy using electromagnetic tracking.
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 step is critical for ensuring the device functions correctly within the navigation system.
The affected instruments were distributed nationwide in the United States and internationally to Canada. The specific lot numbers involved are 17022809, 17030108, 17022207, 17022106, 17020805, 17020904, 17021798, 17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661, 16121260, 16121259, and 16112958. Healthcare facilities should stop using these specific instruments and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Straight Suction 9733449 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. The…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 277
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 (17)
- Lot numbers 17022809
- 17030108
- 17022207
- 17022106
- 17020805
- 17020904
- 17021798
- 17020987
- 17011896
- 17011221
- 17011220
- 16122237
- 16122236
- 16121661
- 16121260
- 16121259
- and 16112958
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 · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateMedtronic Recalls ENT Navigation Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighNon-Invasive Patient Tracker Verification Failure During Image-Guided Surgery
FDA (Devices) · 2023-02-08
- HighMedtronic Recalls AxIEM Touch N Go Pointer Probe for Accuracy Issues
FDA (Devices) · 2017-01-18
- HighMedtronic Recalls Instrument Trackers Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- ModerateMedtronic Recalls AxiEM Tumor Resonance Packs Due to Sterility Concerns
FDA (Devices) · 2014-11-26
- ModerateMedtronic Recalls AxIEM CR Tumor Resection Devices Due to Sterility Concerns
FDA (Devices) · 2014-11-26