AxiumTM APB-2-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847536021174), received between Oct 1, 2018 and May 20, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (10 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM LOCATED ON THE RIGHT BOUTHILLIER CLASSIFICATION C1 WITH A MAX DIAMETER OF 6MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PERFORM EMERGENCY DETACHMENT USING THE DETACHER, BUT SEPARATION COULD NOT BE ACHIEVED, SO IT WAS COLLECTED IN THE CATHETER, SO THE SAME PRODUCT WITH THE SAME LOT WAS USED, BUT THE SAME EVENT OCCURRED, SO IT WAS SWITCHED TO A COIL FROM ANOTHER MANUFACTURER AND THE TREATMENT WAS FINISHED. THERE WAS NO HEALTH IMPACT. TWO COILS AND ONE DETACHER WERE REPORTED. IT WAS STATED THAT THERE WAS POOR WITHDRAWAL. THE PHYSICIAN TRIED 1 TIME TO DISARM THE COIL USING THE INSTANT DETACHER. THERE WAS 1 MANUAL ATTEMPT VIA HYPO TUBE MADE. ALL DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234396 ↗
• InjuryFeb 7, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT REGARDING TWO AXIUM COILS BEING STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3.6 MM AND A 1.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT AS PER OPERATOR THE COIL WAS STRETCHED AND WAS DISTURBING THE COIL MASS. HENCE IT WAS REMOVED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE/STRETCHED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN REPOSITIONED THE COIL DURING THE PROCEDURE TWO TIMES WITH THE FIRST COIL (LOT# B056574) AND ONE TIME WITH THE SECOND COIL (LOT# B008426). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NEURON MAX SHEATH, NEURON GUIDE CATHETER, HEADWAY 17  MICROCATHETER, TRAXCESS GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED WITH NO ABUNDANT AND WAS PLANNED THE NEXT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313712 ↗
• MalfunctionNov 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED WITHOUT ANY ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THEY DID NOT ROTATE THE DELIVERY PUSHER. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A FUBUKI 8F GUIDE CATHETER AND HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826676 ↗
• MalfunctionSep 1, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM COIL BROKE OR SEPARATED PREMATURELY WITHIN THE CATHETER DURING DELIVERY. IT WAS NOTED THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS THE SIXTH TO BE USED IN THE PROCEDURE. NO PARTICULAR RESISTANCE WAS NOTED DURING DELIVERY. THE COIL WAS NOT REPOSITIONED AND THE PUSHER WAS NOT ROTATED IN THE PATIENT. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS REMOVED WITH THE MICROCATHETER AND PUSHED OUT WITH THE GUIDEWIRE. 2 ADDITIONAL COILS WERE THEN USED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INFORMATION WAS REPORTED. ANCILLARY DEVICES: FUBUKI 6F SHEATHLESS TACTICS GUIDE CATHETER, SL-10 MICROCATHETER, CHIKAI14 GUIDEWIRE, TRAXESS GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339854 ↗
• MalfunctionMay 12, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL GOT STUCK INSIDE THE MICROCATHETER, EVENTUALLY A DETACHMENT DID OCCUR INSIDE THE CATHETER. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. ANCILLARY DEVICES INCLUDE: HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379857 ↗
• MalfunctionJan 21, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED AFTER 3 ATTEMPTS WITH THE INSTANT DETACHER. ANOTHER INSTANT DETACHER WAS NOT USED, AND MANUAL DETACHMENT WAS NOT ATTEMPTED. THERE WERE NO PROBLEMS WITH THE INSTANT DETACHER AS IT WAS SUCCESSFULLY USED WITH OTHER COILS BEFORE AND AFTER THE NON-DETACHMENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315832 ↗
• MalfunctionJul 27, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO KINK/DAMAGE WAS OBSERVED TO THE PUSHWIRE, AND THE COIL WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232953 ↗
• MalfunctionFeb 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS PLACED. THREE MODELS OF COILS WERE SELECTED FOR EMBOLIZATION, AND THE HOOP WAS WELL FORMED. HOWEVER, THE REPORTED COIL COULD NOT BE PUSHED OUT OF THE SHEATH. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN CONFIRMED THAT WAS THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375035 ↗
• MalfunctionFeb 18, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS REPOSITIONED TO THE CORRECT POSITION IN THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343246 ↗
• MalfunctionApr 2, 2020Separation Failure; Detachment of Device or Device Component; Unintended Movement; Separation Failure; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER AND DETACHED WHILE PUSHING THE CATHETER. IT WAS ALSO REPORTED THAT PREVIOUSLY IMPLANTED COIL MASS MIGRATED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE IC-OPTHALMIC. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER PLACING A COMPETITOR'S COIL, THE PHYSICIAN CHOOSE AXIUM PRIME 2-2-3D COIL AND IMPLANTED WITHOUT ANY PROBLEM. AFTER THAT, WHEN COMPLETED COILING BY USING THE SAME SIZE OF AXIUM PRIME (PLI 10), THE COILWAS FOUND TO BE NOT DETACHED BY THE DETACHER DURING DETACHMENT. EVEN THOUGH TRIED TO DETACH 2 OR 3 TIMES, DETACHMENT FAILED. WHILE PUSHING THE CATHETER, IT CAME OFF. A BALLOON CATHETER WAS USED IN COMBINATION, AND IT WAS ENTANGLED WITH THE BALLOON, THE COIL MASS WAS SUSPENDED, COMING OUT OF THE ANEURYSM (PLI 30). IT WAS COMPLETELY LEFT IN THE BLOOD VESSEL, AND WAS COLLECTED BY USING SNARE CATHETER. THERE WAS NO PATIENT HARM INDICATED FROM THIS EVENT. ANCILLARY DEVICES INCLUDE A CHIKAI14, SL-10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9918528 ↗
• MalfunctionFeb 4, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH WITH THE INSTANT DETACHER (ID) AND VIA THE MANUAL DETACHMENT METHOD. THE ID WAS USED 2 TIMES AND 1 MANUAL DETACHMENT WAS MADE. A SECOND ID WAS NOT USED. UPON RETRIEVING THE COIL, IT WAS REALIZED THAT THE AXIUM COIL HAD DETACHED WITHIN THE CATHETER. THE TREATING LOCATION AND VESSEL TORTUOSITY IS UNKNOWN. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USED (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9666339 ↗
• MalfunctionJan 10, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH. IT WAS REPORTED THAT THREE ATTEMPTS WERE MADE TO DETACH THE AXIUM COIL WITH THE INSTANT DETACHER (ID-1), BUT IT FAILED. A DIFFERENT INSTANT DETACHER WAS NOT USED, AND NO MANUAL ATTEMPTS WERE MADE. JUDGEMENT FROM THE HEALTHCARE PROVIDER (HCP) DETERMINED IT BEST TO RETRIEVE THE COIL. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN SL-10 STRAIGHT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9577825 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION: THE VESSEL ANATOMY WAS SEVERE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363959 ↗
• MalfunctionNov 19, 2019Separation Failure; Unintended Movement; Migration; Separation Failure; Unintended Movement; Migration

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD DURING THE COILING TREATMENT OF ANEURYSM. THE COIL FINALLY DETACHED AND MIGRATED. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL RUPTURED RIGHT INTERNAL CAROTID POSTERIOR CAROTID ANEURYSM. IT WAS REPORTED THAT THIS COIL WAS USED AS FORTH IN THE PROCEDURE. AN ATTEMPT WAS MADE TO DETACH IT AFTER IT WAS INSERTED SUCCESSFULLY, BUT IT FAILED. THE BREAK INDICATOR WAS BENT, BUT IT WAS UNABLE TO BE DETACHED. THE DEVICE WAS ADVANCED A LITTLE, AND WHEN IT WAS PULLED AND PUSHED REPEATEDLY ABOUT 3 TIMES, THE DEVICE WAS DETACHED. BUT THE COIL MIGRATED FROM THE ANEURYSM, THE COIL WAS MANAGED TO PUT IN THE ANEURYSM WITH ANOTHER COIL AND BALLOON, AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THE DEVICE PREPARED ACCORDING TO THE INSTRUCTIONS PER THE INSTRUCTIONS FOR USE (IFU). FINALLY, THE COMPETITOR'S COIL AND BALLOON WERE USED, EMBOLIZATION WAS PERFORMED ON PURPOSE TO BREAK THE PCOM. FORTUNATELY, PCOM WAS PRESERVED. ACCESSORY DEVICES WERE DISCARDED. THE COIL REMAINS IN THE PATIENT AND THE PUSHWIRE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9343978 ↗
• MalfunctionJun 4, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT, AFTER THE COIL WAS PLACED IN THE INTRODUCER SHEATH AND WHEN ATTEMPTING TO BE DELIVER FROM THE HUB OF THE MICROCATHETER, IT COULD NOT BE DELIVERED FROM THE PART OF THE Y CONNECTOR HUB, NOR COULD IT BE PUSHED SMOOTHLY FROM THE INTRODUCER SHEATH. THE COIL WAS THEN AGAIN ATTEMPTED TO BE PLACED IN THE INTRODUCER SHEATH WHICH RESULTED IN DAMAGE AND PREMATURE DETACHMENT OF THE COIL, AS STATED TO HAVE HAPPENED OUTSIDE THE PATIENT'S BODY. IT WAS NOTED THAT THERE WAS A POSSIBILITY THAT THE PRESSURE OF THE SHEATH WAS INSUFFICIENT. PRIOR TO THE ISSUE THE COIL WAS CHECKED PER THE IFU FOR ABNORMALITIES. AS A RESULT THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS FISTULA/MALFORMATION, LOCATED IN THE FUNCTIONAL AREA OF THE BRAIN. IT WAS NOTED THAT THE BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED PER THE IFU. THERE WAS NO DAMAGE SEEN ON THE CATHETER, NOR WAS THERE RESISTANCE DURING PREPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8669145 ↗
• MalfunctionMay 2, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM IMPLANT COIL COULD NOT BE DETACHED DURING COILING EMBOLIZATION TREATMENT OF AN ANEURYSM. ONE MANUAL DETACHMENT WAS MADE. THE STRAND WAS PULLED A FEW CENTIMETER. THE HYPOTUBE MAY HAVE NOT BEEN BROKEN IN THE CORRECT LOCATION AND THE COIL MAY HAVE BEEN WITHIN THE CATHETER AND NOT COMPLETELY IN THE ANEURYSM DURING THE DETACHMENT ATTEMPT. THE PHYSICIAN DID NOT ATTEMPT TO DETACH WITH ANOTHER INSTANT DETACHER. THE COIL WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE IMPLANT COIL WAS DAMAGED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574540 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED WHILE THE COIL WAS RAISING. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKE. THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. THEY ALSO DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 3MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484230 ↗
• MalfunctionMar 11, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE SECOND COIL (2MM X 2MM) USED IN THE PROCEDURE COULD NOT BE DETACHED WITH THE INSTANT DETACHER AND ALSO COULD NOT BE DETACHED USING THE MANUAL METHOD (BREAKING OF THE HYPTOTUBE, AN ALTERNATIVE DETACHMENT METHOD DESCRIBED IN THE INSTRUCTIONS FOR USE). THE COIL WAS THEN PULLED OUT AND IT DETACHED INSIDE THE MICROCATHETER AS IT WAS BEING RETRIEVED. THE MICROCATHETER AND DETACHED COIL WERE PULLED OUT OF THE PATIENT. THEN, THE PHYSICIAN MANAGED TO PLACE THE MICROCATHETER INTO THE ANEURYSM AGAIN AND USED A NEW COIL OF THE SAME SIZE BUT THE SAME EVENT OCCURRED. THEY REPLACED THE INSTANT DETACHER WITH A NEW ONE BUT THE COIL STILL DID NOT DETACH. THIS COIL EVENTUALLY DETACHED WITH THE MANUAL METHOD. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN ANEURYSM MEASURING 4MM. THE PATIENT¿S VASCULATURE WAS MEDIUM IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410267 ↗
• MalfunctionOct 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING PREPARATION THE PACKAGE OF THE COIL WAS OPENED IN WHICH IT WAS FOUND THAT THE PROXIMAL END OF THE PUSHER WAS STRETCHED. AS A RESULT A NEW DEVICE WAS USED TO COMPLETE THE SURGERY. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY TO TREAT A BRAIN TUMOR. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922446 ↗