CLASS II Device recall · Reported 30 Aug 2017 · FDA Enforcement Report
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx recalled
Medtronic Navigation is recalling Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx, distributed nationwide in the US. The recall was initiated on 29 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3053-2017
- FDA event ID
- 77739
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2017
- FDA classified
- 21 Aug 2017
- Reported
- 30 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 29 Jun 2017 | Recall initiated by company | |
| 21 Aug 2017 | Classified by FDA | +53 days |
| 30 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Product as listed by the FDA
Medtronic Curved Suction 90 9733451 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 AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Where it was distributed
Worldwide Distribution - US (nationwide) and Internationally to Canada.
Questions about this recall
Is Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx recalled?
Yes. Medtronic Navigation recalled Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx on 29 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-3053-2017.
Why was it recalled?
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Which lots are affected?
Lot numbers 17030728, 17022027, 17021426, 17013125, 17012724, 17011303, 16122767, 16122066, 16112965, and 16112164
Where was it sold?
Worldwide Distribution - US (nationwide) and Internationally to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Navigation
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|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation | Medtronic Navigation | Sterility | Nationwide |
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| Device | CLASS I | Stealth S8 Clinical recalled by Medtronic Navigation | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled | Medtronic Navigation | Sterility | Nationwide |
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