N/A 9733449 (UDI 00643169702851)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169702851), received between Apr 13, 2017 and Apr 1, 2019 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K153555); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION WAS DAMAGED AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8471029 ↗
• MalfunctionJan 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STRAIGHT SUCTIONS WERE NOT PHYSICALLY BENT. THE STRAIGHT SUCTION WOULD NOT VERIFY. THE STRAIGHT SUCTIONS WERE NOT USED DURING THE PROCEDURE OR ANY PROCEDURES AFTER THE REPORTED ISSUE. THE ISSUE WAS FOUND OUTSIDE OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258057 ↗
• MalfunctionJan 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STRAIGHT SUCTIONS WERE NOT PHYSICALLY BENT. THE STRAIGHT SUCTION WOULD NOT VERIFY. THE STRAIGHT SUCTIONS WERE NOT USED DURING THE PROCEDURE OR ANY PROCEDURES AFTER THE REPORTED ISSUE. THE ISSUE WAS FOUND OUTSIDE OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258012 ↗
• MalfunctionJan 3, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE STRUGGLED TO VERIFY THE STRAIGHT SUCTION. IT WAS NOTED THAT ITS TRACKING WAS INCONSISTENT. THE SITE USED A MALLEABLE SUCTION AND LATER WERE ABLE TO VERIFY THE STRAIGHT SUCTION. THERE WAS NO PATIENT IMPACT REPORTED AND A LESS THAN ONE HOUR DELAY TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8215741 ↗
• MalfunctionAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED INTRAOPERATIVELY THE SITE WAS NOT ABLE TO VERIFY THE STRAIGHT SUCTION PROBE. OTHER INSTRUMENTS WERE SUCCESSFUL WITH VERIFICATION. THE SITE PROCEEDED WITHOUT USING THE STRAIGHT SUCTION PROBE. NO SURGICAL DELAY WAS REPORTED. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7769898 ↗
• MalfunctionJun 29, 2018Bent; Bent

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A REPRESENTATIVE DISCOVERED TWO DAMAGED STRAIGHT SUCTIONS AT THE SITE.

  Patient problems: No Patient Involvement

  MAUDE report 7653273 ↗
• MalfunctionJun 29, 2018Bent; Bent

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A REPRESENTATIVE DISCOVERED TWO DAMAGED STRAIGHT SUCTIONS AT THE SITE. THIS ISSUE OCCURRED OUTSIDE OF PROCEDURE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7653208 ↗
• MalfunctionJun 4, 2018Bent; Material Deformation; Bent; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE HAD TROUBLE VERIFYING THE STRAIGHT SUCTION. THE SITE USED A DIFFERENT STRAIGHT SUCTION AND WAS SUCCESSFUL. SURGERY WAS DELAYED FOR 10 MIN AND THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567382 ↗
• MalfunctionFeb 19, 2018Device Stops Intermittently; Device Stops Intermittently

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE STRAIGHT SUCTION EXPERIENCED DIFFICULTIES VERIFYING. IT WAS NOTED THAT AFTER VERIFICATION, THE SUCTION WOULD NOT TRACK ON THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7280875 ↗
• MalfunctionOct 12, 2017Imprecision; Device Operates Differently Than Expected; Imprecision; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SURGEON WAS UNABLE TO VERIFY THE STRAIGHT SUCTION. THE SURGEON REPORTED THAT TURNING THE SUCTION AROUND ALLOWED VERIFICATION THROUGH AN IMPRECISION WAS OBSERVED BETWEEN 2-3 MILLIMETERS. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITH THE SUCTION. IT WAS NOTED THAT THE PATIENT'S HEAD AND THE EMITTER WERE SEPARATED PROPERLY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946244 ↗
• MalfunctionOct 6, 2017Communication or Transmission Problem; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) THE STRAIGHT SUCTION WAS UNABLE TO BE RECOGNIZED BY NAVIGATION SYSTEM. SITE SUSPECTED THAT THE SUCTION TIP MIGHT HAVE BEEN SHAVED BY A DRILL. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925765 ↗
• MalfunctionSep 11, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE STRAIGHT SUCTION IN USE WAS HAVING ISSUES WITH VERIFICATION. IT WAS REPORTED THAT THE DISTANCE TO DIVOT WAS BETWEEN 2.1 AND 2.4, EXCEEDING SPECIFICATIONS. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856190 ↗
• MalfunctionJun 22, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE TIP OF THE STRAIGHT SUCTION BECAME BENT. THE REPORTED ISSUE OCCURRED WHILE NAVIGATING AND THE SITE CONTINUED WITH THE PROCEDURE WITH A SEPARATE SUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6661040 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE STRAIGHT SUCTION INSTRUMENT HAD TO BE MANIPULATED TO VERIFY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6592340 ↗
• MalfunctionMay 2, 2017Imprecision; Device Operates Differently Than Expected; Imprecision; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SURGEON FELT AN IMPRECISION WHEN USING THE STRAIGHT SUCTION. ALL OTHER INSTRUMENTS WERE ACCURATE. THE DISTANCE TO DIVOT WAS REPORTED TO BE WITHIN ACCEPTABLE LIMITS AND THE TRACKER WAS RESEATED WITHOUT RESOLUTION. THE SURGEON OPTED TO CONTINUE THE PROCEDURE WITH THE SUSPECT SUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538184 ↗
• MalfunctionApr 21, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE TIP OF THE STRAIGHT SUCTION WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. NO INDICATION OF HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511093 ↗
• MalfunctionApr 13, 2017Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAD REGISTERED THE PATIENT TWICE AND WERE ACCURATE ON THE SKIN, BUT WHEN ENTERING THE NOSE DURING THE CASE, THERE WAS AN INACCURACY. THE SITE HAD A GOOD TRACING PATTERN AND THE EXAM QUALITY WAS FINE. THE MEDTRONIC REPRESENTATIVE ARRIVED AND RE-TRACED THE PATIENT BUT WAS HAVING DIFFICULTY VERIFYING THE STRAIGHT SUCTION; IT HAD A HIGHER DISTANCE TO DIVOT. THE SITE WAS EVENTUALLY ABLE TO VERIFY THE STRAIGHT SUCTION, BUT IT WAS AGAIN OFF BY 1MM. THE SITE THEN BROUGHT OTHER INSTRUMENTS INTO THE FIELD WHICH WERE ACCURATE, BUT THE SUCTION WASN'T. THE PHYSICIAN TOOK INTO ACCOUNT THE INACCURACY AND PROCEEDED WITH THE SURGERY. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153555. One submission often covers many models, so check the product and lot details in each record.

• Z-3058-2017 · Jun 29, 2017 · Terminated
  Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Sucti
• Z-3057-2017 · Jun 29, 2017 · Terminated
  Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc.,
• Z-3054-2017 · Jun 29, 2017 · Terminated
  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 reus
• Z-3051-2017 · Jun 29, 2017 · Terminated
  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 reus
• Z-3056-2017 · Jun 29, 2017 · Terminated
  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
• Z-3053-2017 · Jun 29, 2017 · Terminated
  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 re
• Z-3055-2017 · Jun 29, 2017 · Terminated
  Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg C
• Z-3052-2017 · Jun 29, 2017 · Terminated
  Medtronic Curved Suction 70 9733450 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 reu