CLASS II Device recall · Reported 30 Aug 2017 · FDA Enforcement Report

Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX recalled

Medtronic Navigation is recalling Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452, 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

Lot, batch or date codesEach of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Quantity recalled15 kits

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-3056-2017
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 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 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.

Nationwide

Questions about this recall

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?

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 77739

This product is part of a recall event; the main page for the event is Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx recalled.

Reported	Class	Recall	Company	Reason	Where
30 Aug 2017	CLASS II	Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx recalled	Medtronic Navigation	Other	Nationwide
30 Aug 2017	CLASS II	Medtronic Instrument Set EM ENT recalled by Medtronic Navigation	Medtronic Navigation	Other	Nationwide
30 Aug 2017	CLASS II	Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx recalled	Medtronic Navigation	Other	Nationwide
30 Aug 2017	CLASS II	Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx recalled	Medtronic Navigation	Other	Nationwide
30 Aug 2017	CLASS II	Medtronic Set Supplemental INS AxiEM ENT recalled	Medtronic Navigation	Other	Nationwide
30 Aug 2017	CLASS II	Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx recalled	Medtronic Navigation	Other	Nationwide
30 Aug 2017	CLASS II	Medtronic Straight Suction 9733449 EM ENT, reusable, Rx recalled	Medtronic Navigation	Other	Nationwide

More recalls from Medtronic Navigation

All 92

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Other	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 1.3.0 and 1.3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Other	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

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9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide