Resolute Onyx™ RONYX20008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169556621), received between Jul 23, 2018 and Jan 10, 2024 — classified as 2 deaths, 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WASN'T POSSIBLE TO REMOVE THE STENT AND IT WAS OBSTRUCTING FLOW. THE STENT WAS CRUSHED WITH A NON-MEDTRONIC STENT. IT WAS INTENDED TO USE ANOTHER RESOLUTE ONYX STENT. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON ON THE TABLE PRIOR TO INSERTION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18484167 ↗
• InjuryJul 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN A DISTAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT IN VIVO OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT AND ANOTHER STENT WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15119262 ↗
• MalfunctionJul 11, 2022Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION LOCATED IN THE BRAIN. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED. THE DEVICE WAS BEING USED OFF-LABEL AND WAS ATTEMPTED TO BE USED IN THE BRAIN. IT WAS REPORTED THAT THE CATHETER DEFORMED/KINKED AND BROKE JUST DISTAL TO THE HUB. IT WAS STATED THAT THE PHYSICIAN SAID RESISTANCE WAS ENCOUNTERED BUT KEPT PUSHING THE DEVICE. EVENTUALLY THE DEVICE KINKED/BROKE. THE DEVICE WAS ABLE TO BE REMOVED WITH NO ISSUES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14974744 ↗
• MalfunctionJun 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IT WAS REPORTED THAT GUIDEWIRE MOVEMENT ISSUES OCCURRED WHEN INSERTING THE STENT PAST THE TUOHY AND ADVANCING UP THE INTERNAL LUMEN OF THE GUIDE. THE DEVICE WAS UNABLE TO BE REMOVED FROM THE GUIDEWIRE. THE GUIDE CATHETER, GUIDE WIRE AND STENT DEVICE WERE ALL REMOVED TOGETHER WITHOUT INCIDENT. IT WAS STATED THAT THE STENT DID NOT EXIT THE DISTAL END OF THE GUIDE CATHETER OR COME INTO CONTACT WITH THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE WIRE, A NEW GUIDE CATHETER AND A NEW RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14618704 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, THREE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED. IT WAS REPORTED THAT THE STENTS HAVE 100% OCCLUSION AND THE PATIENT WILL NEED A BYPASS SURGERY TO TREAT THE BLOCKED STENTS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12670600 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FOUR RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS LATER THE PATIENT SUFFERED NON-TARGET VESSEL MYOCARDIAL INFARCTION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. CEC ADJUDICATED THE EVENT AS MI (VESSEL UNKNOWN).

  Patient problems: Myocardial Infarction

  MAUDE report 10800844 ↗
• DeathMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. SEVEN MEDTRONIC PTA BALLOONS WERE ALSO USED DURING PROCEDURE. APPROXIMATELY 32 MONTHS POST PROCEDURE, PATIENT SUFFERED UNSTABLE ANGINA WITH KNOWN CORONARY ARTERY DISEASE AND WAS TREATED WITH CHANGE IN MEDICATION. A MONTH LATER, PATIENT EXPIRED. DEATH IS OF UNKNOWN CLASSIFICATION. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10074214 ↗
• DeathApr 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, ONE RESOLUTE ONYX RX (2.00X12) WAS ATTEMPTED TO BE USED AND ONE RESOLUTE ONYX RX (2.00X08) WAS IMPLANTED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE RESOLUTE ONYX (2.00X12) STENT FAILED TO CROSS THE LESION. THE LESION WAS TREATED BY PRE-DILATION USING A NON MEDTRONIC BALLOON AND A RESOLUTE ONYX (2.00X08) WAS IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST AND DECEASED FOLLOWING THE PROCEDURE.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 10004210 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE A PATIENT WAS IMPLANTED WITH A RESOLUTE ONYX DRUG ELUTING STENT. IT WAS REPORTED THAT THE PATIENT WAS IN PAIN AND EXHIBITED BRUISING AT THE TIME OF THE EVENT AT THE ENTRY SITE AND ALSO EXPERIENCED SWOLLEN FEET. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED AND THE PATIENT EXPERIENCED AN EMBOLISM AND CODED DURING THE PROCEDURE. IT WAS STATED THAT THE PATIENT HAD HIGH BLOOD PRESSURE AND THAT THE PATIENT'S HYPOTENSION OR PLAQUE MAY HAVE CAUSED THE RUPTURE. THE RUPTURED BALLOON WAS REPLACED. IT WAS ADVISED THAT IT IS UNKNOWN IF THE BALLOON THAT RUPTURED WAS A MEDTRONIC DEVICE.

  Patient problems: Embolism

  MAUDE report 9309544 ↗
• InjuryNov 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS UNABLE TO BE REMOVED AND A BALLOON WAS INSERTED IN AN ATTEMPT TO CRUSH THE STENT AGAINST THE VESSEL WALL. THE DISLODGED STENT REMAINS IN THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9308991 ↗
• MalfunctionMar 28, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION IN THE PROXIMAL PORTION OF AN ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO WHEN PULLING THE STENT BACK INTO THE GUIDELINER. IT WAS INDICATED THAT A STRUT OF THE STENT GOT CAUGHT ON THE EDGE OF THE GUIDELINER AND LIFTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460360 ↗
• InjuryMar 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WERE ABNORMALITIES REPORTED IN RELATION TO THE PATIENT ANATOMY, THAT THERE WAS A SHARP 90 DEGREE TAKEOFF. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED SEVERAL TIMES WITH A SEMI COMPLIANT BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE SEVERAL ATTEMPTS WERE MADE CROSS THE LESION USING THE RESOLUTE ONYX STENT WITHOUT SUCCESS. DURING REMOVAL OF THE DEVICE, THE STENT DISLODGED OFF THE BALLOON IN THE OSTIAL LAD. THE STENT WAS RETRIEVED AND LOCATED IN THE CATHETER. IT IS INDICATED THAT THE EVENT WAS DUE TO THE COMPLEXITY OF THE ANATOMY AND THE DEVICE WAS NOT AT FAULT. THE PATIENT IS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8386353 ↗
• MalfunctionJan 16, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  THE PATIENT PRESENTED WITH A STEMI. AN ATTEMPT WAS MADE TO USE THREE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SIGNIFICANTLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 100% STENOSIS LOCATED IN THE 1ST DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. IT IS INDICATED THAT AFTER PRE-DILATION THERE WAS 50% STENOSIS REMAINING. THE DEVICES DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENTS. IT IS STATED THAT A SIGNIFICANT AMOUNT OF FORCE WAS USED DURING ATTEMPT TO DELIVER. IT IS STATED THAT A SUPPORTIVE GUIDEWIRE AND ALSO A GUIDELINER WERE USED IN THE ATTEMPT TO CROSS THE LESION. IT WAS REPORTED THAT ALL THREE STENTS WERE ATTEMPTED TO BE USED BUT ALL FAILED TO CROSS THE LESION. UPON REMOVAL OF THE 2.0X22MM AND 2.0X12MM STENTS, STENT DEFORMATION WAS OBSERVED. IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE 2.0X8MM STENT FOLLOWING FAILED DELIVERY THAT IT DISLODGED INSIDE THE GUIDE LINER CATHETER. IT IS INDICATED THAT THE STENT WAS NEVER LOST IN THE PATIENT, IT WAS OFF OF THE STENT DELIVERY SYSTEM AFTER WITHDRAWAL FROM THE BODY. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251913 ↗
• MalfunctionNov 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE OSTIUM OF THE SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THERE WAS NO INTERVENTION ATTEMPTED TO REMOVE THE DISLODGED STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8099706 ↗
• MalfunctionSep 25, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS (RONYX20015UX) AND (RONYX20008UX) TO TREAT A MODERATELY TORTUOUS AND NON- CALCIFIED LESION LOCATED IN THE MID/DISTAL RAMUS EXHIBITING 70% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THERE WAS AN INITIAL 99% SUB TOTALED LESION OF THE PROXIMAL RAMUS INTERMEDIUS BRANCH. A 2.25X15MM ONYX WAS SUCCESSFULLY DEPLOYED, A RESIDUAL 70% STENOSIS WAS NOTED DISTAL TO THE ORIGINAL STENT. THIS LESION WAS PRE-DILATED WITH A SEMI COMPLIANT BALLOON, THE 2.0X15MM ONYX WAS THEN ATTEMPTED TO PASS THROUGH THE PREVIOUSLY DEPLOYED STENT WITHOUT SUCCESS, A STENT STRUT WAS NOTED TO BE LIFTED UPON REMOVING THE STENT. A NON-MEDTRONIC EXTENSION CATHETER WAS INTRODUCED TO GIVE MORE SUPPORT. THEN THE 2.0X8MM ONYX WAS ATTEMPTED TO P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904808 ↗
• MalfunctionJul 23, 2018Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated

  TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE INTENDED TO BE USED TO TREAT A MODERATELY CALCIFIED MODERATELY TORTUOUS LESION IN THE 1ST OM. STENOSIS WAS 85%. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICES INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. A NON-MEDTRONIC STENT WAS IMPLANTED FIRST IN THE 1ST OM. AFTER THIS STENT WAS IMPLANTED IT WAS THOUGHT THAT SOME OF THE BURDEN HAD MOVED INTO THE DISTAL SEGMENT OF THE VESSEL. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE RESOLUTE ONYX DEVICES. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICES TO THE LESION. EXCESSIVE FORCE WAS USED. THERE WAS A DIFFICULTY CROSSING THE LESION. THE TWO STENTS DID NOT MAKE IT THROUGH THE NON-MEDTRONIC STENT. THE FIRST RESOLUTE ONYX STENT SLID UP THE SHAFT. THE WHOLE SYSTEM WAS WITHDRAWN AND THE STENT WAS ON THE SHAFT OF THE STENT CATHETER. THE SECOND RESOLUTE ONYX STENT WAS MOVING UNDER THE BALLOON WHEN THE SYSTEM WAS WITHDRAWN. THE STENT WAS REMOVED WITHOUT AN ISSUE ON THE STENT CATHE TER, BUT THE STENT ACTUALLY CAME OFF THE BALLOON AS IT WAS REMOVED FROM THE VALVE OF THE SHEATH. THE SHEATH AND GUIDE WERE EXCHANGED AND THE GUID

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

  MAUDE report 7710307 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated

  TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE INTENDED TO BE USED TO TREAT A MODERATELY CALCIFIED MODERATELY TORTUOUS LESION IN THE 1ST OM. STENOSIS WAS 85%. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICES INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. A NON-MEDTRONIC STENT WAS IMPLANTED FIRST IN THE 1ST OM. AFTER THIS STENT WAS IMPLANTED IT WAS THOUGHT THAT SOME OF THE BURDEN HAD MOVED INTO THE DISTAL SEGMENT OF THE VESSEL. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE RESOLUTE ONYX DEVICES. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICES TO THE LESION. EXCESSIVE FORCE WAS USED. THERE WAS A DIFFICULTY CROSSING THE LESION. THE TWO STENTS DID NOT MAKE IT THROUGH THE NON-MEDTRONIC STENT. THE FIRST RESOLUTE ONYX STENT SLID UP THE SHAFT. THE WHOLE SYSTEM WAS WITHDRAWN AND THE STENT WAS ON THE SHAFT OF THE STENT CATHETER. THE SECOND RESOLUTE ONYX STENT WAS MOVING UNDER THE BALLOON WHEN THE SYSTEM WAS WITHDRAWN. THE STENT WAS REMOVED WITHOUT AN ISSUE ON THE STENT CATHETER, BUT THE STENT ACTUALLY CAME OFF THE BALLOON AS IT WAS REMOVED FROM THE VALVE OF THE SHEATH. THE SHEATH AND GUIDE WERE EXCHANGED AND THE GUIDE

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

  MAUDE report 7710254 ↗