Medtronic Fusion ENT Instrument Kit Recalled for Verification Failure
Medtronic is recalling 15 Fusion ENT Instrument Kits because the instruments fail pre-use verification. The kits were distributed in the US and Canada.
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 actual injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is recalling 15 units of the Medtronic Instrument Kit 9733908 Fusion ENT. These reusable, prescription-only kits contain straight and curved suction devices used with the StealthStation AxiEM surgical navigation system for ENT procedures. The kits 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. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and customers who possess these specific reusable suction devices should stop using them and contact Medtronic Navigation, Inc. for instructions on how to return or replace the affected instruments.
The recalled product
- Product
- Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 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., Louisville, CO. The…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 15
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
- ModerateMedtronic ENT Instrument Set Recalled for Verification Failure
FDA (Devices) · 2017-08-30
Similar recalls
- ModerateMedtronic Recalls ENT Navigation Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighMedtronic Recalls Instrument Trackers Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- ModerateMedtronic Navigation Recalls Fusion ENT Software Application
FDA (Devices) · 2016-08-10
- HighMedtronic Recalls Patient Tracker Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- ModerateMedtronic Recalls BioTex Reusable Adapter Kits Lacking FDA Clearance
FDA (Devices) · 2016-03-30
- HighMedtronic Surgical Blades Recalled Due to Tip Breaks and Vibration
FDA (Devices) · 2021-10-27