Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 30, 2017
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 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 to
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Navigation, Inc. recalled Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is M… - a moderate-severity action.
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is M… was recalled by Medtronic Navigation, Inc. in August 30, 2017. Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each inst…. Check the official notice for the remedy. Verify recall #Z-3051-2017 with the FDA Devices before acting.
The recall
Medtronic Navigation, Inc. issued this moderate-severity FDA Devices recall-The instruments are not able to pass instrument verification which is performed prior to the use of each inst….
- Moderate
- severity level
- Class II
- classification
- August 30, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3051-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3051-2017) was formally reported on August 30, 2017, with the manufacturer initiating the action on June 29, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Navigation, Inc. is listed as the recalling firm, operating out of Louisville, CO. Federal records list the affected scope as 277 instruments.
The documented reason for this recall is: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and Internationally to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
277 instruments
Related Recalls
6
0 from same agency
Product description
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 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
Reason for recall
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3051-2017 |
| Date reported | August 30, 2017 |
| Date initiated | June 29, 2017 |
| Recalling firm | Medtronic Navigation, Inc. |
| Firm location | Louisville, CO |
| Affected scope | 277 instruments |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3051-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 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. Recalled by Medtronic Navigation, Inc.. Units affected: 277 instruments.
Why was this product recalled? ▼
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2017. Severity: Moderate. Recall number: Z-3051-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3051-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 30, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.