Medtronic Curved Suction 70 Recalled for Verification Failure
Medtronic is recalling 149 Curved Suction 70 ENT instruments 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 product (surgical instrument) where the defect prevents accurate tracking, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Navigation, Inc. is recalling 149 units of the Curved Suction 70 9733450 EM ENT instrument. These reusable, prescription-only devices are used with the StealthStation AxiEM surgical navigation system for ENT procedures. The affected instruments are identified by specific lot numbers listed in the recall notice.
The recall was initiated because the instruments are unable to pass instrument verification, a mandatory check performed prior to the use of each instrument. This failure prevents the surgical navigation system from accurately tracking the instrument tip in relation to patient anatomy.
The affected products were distributed nationwide in the United States and internationally to Canada. Healthcare facilities and users should stop using the affected instruments and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Curved Suction 70 9733450 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.…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 149
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 (12)
- Lot numbers 17030722
- 17022421
- 17022020
- 17020619
- 17011918
- 17012417
- I 17010602
- 16122724
- 16122239
- 16122038
- 16120563
- and 16112362
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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