Medtronic AxiEM ENT Suction Devices Recalled for Verification Failure
Medtronic is recalling 60 reusable ENT suction instruments because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
What this means for you
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 high-risk medical device where the failure to pass verification poses a risk of harm to patients, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Navigation, Inc. is recalling 60 units of the Medtronic Suction 9734308 Small AxiEM ENT reusable instrument. These devices are prescription-only and are used as suction and pointing tools in conjunction with the StealthStation AxiEM surgical navigation system. The recall covers specific lot numbers: 17022451, 17011750, 16120349, 16082989, 16081888, 16071987, 16062713, and 16060712.
The recall was initiated because the instruments are unable to pass instrument verification, a process that must be performed prior to the use of each instrument. The AxiEM system relies on electromagnetic tracking to compute the position and orientation of the instrument tip relative to patient anatomy. If the instrument cannot pass verification, the tracking functionality may be compromised.
The affected instruments were distributed nationwide in the United States and internationally to Canada. Healthcare facilities and users of these specific instruments should stop using them and contact Medtronic Navigation, Inc. for instructions on how to proceed.
The recalled product
- Product
- Medtronic Suction 9734308 Small AxiEM 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.
- Affected units
- 60
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 (8)
- Lot numbers 17022451
- 17011750
- 16120349
- 16082989
- 16081888
- 16071987
- 16062713
- and 16060712
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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