The Recall Desk
HighFDA (Devices)·Z-3051-2017·Announced 2017-08-30

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.

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 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.
Category
Medical Device — Surgical Instrument
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.

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Same hazard · device malfunction

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