Penumbra System PMX110Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 00814548012773), received between Aug 13, 2015 and Oct 27, 2020 — classified as 166 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (32 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 25 most recent of 166 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Misconnection; Device Contamination with Body Fluid; Device Handling Problem; Misconnection; Device Contamination with Body Fluid; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON ILIAC ARTERY USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN TO THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX. THEREFORE, THE PUMP MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA ENGINE (ENGINE). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10741288 ↗
• MalfunctionAug 4, 2020Misconnection; Misconnection

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, A HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX; THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365457 ↗
• MalfunctionJul 30, 2020Suction Problem; Suction Failure; Suction Problem; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PUMP MAX DID NOT GENERATE VACUUM PRESSURE. AN ATTEMPT WAS MADE TO TROUBLESHOOT THE PUMP MAX BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE REGULATORY KNOB WAS LOOSE, SPINNING AND NOT CATCHING ON THE DIAL. SUBSEQUENTLY, NOT ALLOWING THE VACUUM PRESSURE TO BE ADJUSTED UPWARD. THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PHYSICIAN DECIDED TO ABANDON THE THROMBUS ASPIRATION AND OPTED TO ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347994 ↗
• MalfunctionJul 3, 2020Misconnection; Misconnection

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, A HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX; THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY AND STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228218 ↗
• MalfunctionMar 6, 2020Decrease in Suction; Device Emits Odor; Decrease in Suction; Device Emits Odor

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE MAXIMUM VACUUM PRESSURE THAT THE PUMP MAX GENERATED WAS -22 MMHG. IT WAS REPORTED THAT THIS WAS NOT ENOUGH VACUUM PRESSURE TO ASPIRATE THE THROMBUS; THEREFORE, THE PUMP MAX WAS DISCONNECTED. IT WAS ALSO REPORTED THAT THE PUMP MAX EMITTED A BURNING SMELL. THE PROCEDURE WAS COMPLETED USING A NEW PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801880 ↗
• MalfunctionFeb 27, 2020Misconnection; Device Contamination with Body Fluid; Device Handling Problem; Misconnection; Device Contamination with Body Fluid; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766771 ↗
• MalfunctionFeb 13, 2020Misconnection; Device Contamination with Body Fluid; Misconnection; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS INADVERTENTLY CONNECTED TO THE PUMP MAX RATHER THAN THE PUMP MAX CANISTER (CANISTER). BLOOD WAS THEN ASPIRATED INTO THE PUMP MAX; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A MANUAL ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708953 ↗
• MalfunctionDec 20, 2019Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, A HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX; THEREFORE, THE PUMP MAX WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506395 ↗
• MalfunctionDec 20, 2019Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, IT WAS REPORTED THAT THE ASPIRATION WAS NOT HOLDING. THEREFORE, THE PUMP MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505185 ↗
• MalfunctionNov 4, 2019Decrease in Suction; Decrease in Suction

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, IT WAS REPORTED THAT THE FLOW THROUGH THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND INTO THE INDIGO PUMP MAX CANISTER (CANISTER) WAS VERY SLOW. THE PHYSICIAN THEN FOUND THAT THE PUMP MAX WAS UNABLE TO PRODUCE MAXIMUM ASPIRATION AND WAS ONLY ABLE TO REACH -18 IN HG. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PUMP MAX FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273207 ↗
• MalfunctionSep 4, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX WOULD NOT TURN ON. THE PROCEDURE WAS COMPLETED USING A SYRINGE ASPIRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962992 ↗
• MalfunctionJul 25, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CIRCUMFLEX ARTERY USING AN INDIGO SYSTEM CAT RX KIT, AN INDIGO PUMP MAX CANISTER (CANISTER), A PUMP MAX CANISTER (CANISTER), AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) INTO THE TARGET VESSEL, CONNECTED THE PUMP MAX AND INITIATED THE ASPIRATION; HOWEVER, NO VACUUM WAS PRODUCED. THEREFORE, THE CATRX AND CANISTER WERE REMOVED. THE PHYSICIAN THEN PLACED A NEW CATRX AND CANISTER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER THROMBECTOMY DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826470 ↗
• MalfunctionJul 24, 2019Misconnection; Use of Device Problem; Device Contamination with Body Fluid; Misconnection; Use of Device Problem; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS INADVERTENTLY CONNECTED DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX. HOWEVER, THE PHYSICIAN DECIDED TO USE THE SAME PUMP MAX TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822456 ↗
• MalfunctionJun 6, 2019Misconnection; Device Contamination with Body Fluid; Device Handling Problem; Misconnection; Device Contamination with Body Fluid; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS INADVERTENTLY MISCONNECTED TO THE PUMP MAX AND CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE BODY OF THE PUMP MAX. THEREFORE, THE PUMP MAX IS NO LONGER WORKING, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674595 ↗
• MalfunctionJun 5, 2019Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND ASPIRATION TUBING (TUBING) WAS ACCIDENTALLY CONNECTED DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX. THE PHYSICIAN HAD A SUCCESSFUL RECANALIZATION USING THE SAME PUMP MAX, 3MAXC AND TUBING AFTER A SINGLE PASS AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671256 ↗
• MalfunctionMay 9, 2019Failure to Power Up; Failure to Power Up

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN TRIED TO USE MULTIPLE POWER CORDS AND DIFFERENT POWER OUTLETS; HOWEVER, THE PUMP MAX WOULD NOT TURN ON. THEREFORE, THE PUMP MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597385 ↗
• MalfunctionMay 8, 2019Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS INADVERTENTLY MISCONNECTED TO THE PUMP MAX AND CONSEQUENTLY, BLOOD WAS ASPIRATED DIRECTLY INTO THE PUMP MAX. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593148 ↗
• MalfunctionMay 8, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY, POSTERIOR TIBIAL ARTERY AND THE PERONEAL ARTERY USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED THE CONTROL KNOB TO BE LOOSE; HOWEVER, THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591112 ↗
• MalfunctionMay 8, 2019Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE PUMP MAX AND REPORTED THAT IT BEGAN MAKING NOISE AND OVERHEATING. THE PUMP MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8590617 ↗
• MalfunctionApr 26, 2019Connection Problem; Pumping Problem; Connection Problem; Pumping Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX WAS NOT FUNCTIONING PROPERLY AFTER IT WAS POWERED ON. UPON INSPECTION, THE HOSPITAL STAFF NOTICED THAT A CONNECTOR WAS ¿UNFIXED¿. THEREFORE, THE PROCEDURE WAS COMPLETED USING A DIFFERENT PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556624 ↗
• MalfunctionApr 5, 2019Excessive Heating; Excessive Heating

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, AFTER APPROXIMATELY 90 MINUTES OF INTERMITTENT ASPIRATION USING THE PUMP MAX, A PENUMBRA FIELD REPRESENTATIVE NOTICED THAT THE PUMP MAX BECAME HOT AND WAS, THEREFORE, TURNED OFF. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ASPIRATE THE DISTAL SEGMENT OF THE PULMONARY BRANCH. THE PUMP MAX WAS NOT TURNED ON AGAIN TO PREVENT FURTHER DAMAGE. THE PROCEDURE WAS ENDED AT THIS POINT DUE TO NO ADDITIONAL PUMP MAXS BEING AVAILABLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489614 ↗
• MalfunctionMar 28, 2019Device Emits Odor; Suction Problem; Excessive Heating; Device Emits Odor; Suction Problem; Excessive Heating

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PUMP MAX HAD GOTTEN VERY WARM AND SMELLED HOT. IT WAS REPORTED THAT THE PUMP MAX ALSO HAD REDUCED ASPIRATION POWER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. THE PATIENT HAD DEFICITS POST PROCEDURE CAUSED BY THE INDEX STROKE THAT THE PATIENT WAS ORIGINALLY BEING TREATED FOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462829 ↗
• MalfunctionMar 27, 2019Contamination; Misconnection; Device Contamination with Chemical or Other Material; Contamination; Misconnection; Device Contamination with Chemical or Other Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX WAS INADVERTENTLY SET UP INCORRECTLY AND, CONSEQUENTLY, SALINE WAS ASPIRATED INTO THE BODY OF THE PUMP MAX RATHER THAN THE INDIGO PUMP MAX CANISTER (CANISTER). THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458178 ↗
• MalfunctionMar 26, 2019Suction Problem; Suction Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) WOULD TURN ON; HOWEVER, IT DID NOT PRODUCE ASPIRATION. THE ISSUE WITH THE PUMP MAX WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 8453720 ↗
• MalfunctionMar 19, 2019Contamination; Misconnection; Device Contamination with Body Fluid; Contamination; Misconnection; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. AS A RESULT, THE BLOOD WAS ASPIRATED INTO THE PUMP MAX. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX AND NON-PENUMBRA DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434938 ↗