SMART FLEXRecalls & reported problems across all models

We found 22 models of SMART FLEX by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2022 and Mar 22, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (8 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SMART FLEX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 15, 2017Terminated

   Potential for cracked luer hubs

   Z-0324-2018 · Root cause: Nonconforming Material/Component · names 17 of these models · Recall details · FDA record ↗

Most reported SMART FLEX problems

SMART FLEX models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SMART FLEX SF06150MB

  Stents, drains and dilators for the biliary ducts
  1 recall3 reports
• SMART FLEX SF07150MB

  Stents, drains and dilators for the biliary ducts
  1 recall1 report
• SMART FLEX SF06100MB

  Stents, drains and dilators for the biliary ducts
  1 recall1 report
• SMART FLEX SF10040SB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF05100MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF07100MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF08100MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF06120MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF07080MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF09100SB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF09060SB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF10060SB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF09080MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF09030MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF09060MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF10100MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF08120MB

  Stents, drains and dilators for the biliary ducts
  1 recall0 reports
• SMART FLEX SF08150MB

  Stents, drains and dilators for the biliary ducts
  2 reports
• SMART FLEX SF05040MB

  Stents, drains and dilators for the biliary ducts
  2 reports
• SMART FLEX SF10100SB

  Stents, drains and dilators for the biliary ducts
  1 report
• SMART FLEX SF06040MB

  Stents, drains and dilators for the biliary ducts
  1 report
• SMART FLEX SF06060MB

  Stents, drains and dilators for the biliary ducts
  1 report

Recent SMART FLEX adverse event reports

The 12 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  AS REPORTED, DURING ATTEMPTED DEPLOYMENT OF AN 8MM X 150MM SMART FLEX BILIARY SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE SYSTEM WAS STUCK 1/3RD OF THE WAY DURING UNSHEATHING OF THE STENT. A POPPING NOISE WAS OBSERVED, AND THE STENT WAS PULLED BACK AND STARTED DEPLOYING INTO THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE STENT WAS DEPLOYED WITHOUT ANY OBSERVED DAMAGE OBSERVED VIA FLUOROSCOPY. IT WAS REPORTED THAT THE STENT WAS INTENTIONALLY DEPLOYED BUT WAS IMPLANTED IN AN UNINTENDED LOCATION. THERE WAS SOME DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT AND THE OUTER CATHETER HAD SEPARATED AFTER PULLING ON THE DEVICE TO REMOVE IT. HOWEVER, THE SEPARATED OUTER SHEATH WAS ABLE TO BE REMOVED TOGETHER WITH THE DELIVERY SYSTEM. AN 8MM X 150MM NON-CORDIS SES WAS USED AND WAS DEPLOYED INTO THE INTENDED DISTAL SFA TARGET LESION. THERE WAS NO FOREIGN BODY LEFT WITHIN THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 95% STENOSED LESION WHICH HAD SEVERE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS HELD FLAT AND STRAIGHT DURING ITS USE.A6F 45CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS USED FOR THIS PROCEDURE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961481 ↗
• InjuryOct 23, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING DEPLOYMENT OF A 6MM X 100MM 120CM SMART FLEX BILIARY SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE PHYSICIAN FULLY LOOSENED THE TOUHY BORST VALVE TO INITIATE STENT DEPLOYMENT. THEIR HANDS WERE PLACED ON THE TOUHY VALVE AND THE METAL PUSH ROD, AND THE STENT DEPLOYMENT WAS PERFORMED VIA THE PIN AND PULL METHOD. THE USER HELD THE HANDLE OF THE DELIVERY SYSTEM FLAT AND STRAIGHT OUTSIDE OF THE PATIENT DURING ATTEMPTED DEPLOYMENT. HOWEVER, RESISTANCE WAS FELT, AND THE PHYSICIAN HAD TO INCREASE THE FORCE OF THE PIN AND PULL WHICH CAUSED THE Y-ADAPTOR TO DISLODGE FROM THE OUTER LAYER OF THE SDS. THE DETACHMENT OF THE TOUHY VALVE MADE THE DEPLOYMENT OF THE STENT DIFFICULT TO PERFORM AND THE STENT WAS PARTIALLY DEPLOYED. THE PHYSICIAN WAS ADVISED TO PULL BACK ON THE SDS TO CONTINUE DEPLOYMENT; HOWEVER, THIS CAUSED THE PARTIALLY DEPLOYED SDS TO MIGRATE PROXIMALLY. THE PHYSICIAN ATTEMPTED TO REMOVE THE PARTIALLY DEPLOYED STENT THROUGH A NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WHILE THE STENT WAS STILL ATTACHED TO THE DELIVERY SYSTEM; HOWEVER, THE REMOVAL WAS UNSUCCESSFUL, AND THE STENT WAS DEPLOYED PROXIMALLY TO ITS INTENDED LOCATION. AS A RESULT, A NEW 6MM X 120MM SM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984743 ↗
• InjuryJul 14, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHEN DEPLOYING THE SMART FLEX 7X150 BIL STENT FROM A PEDAL ACCESS APPROACH IN THE DISTAL SFA, THE SHAFT WAS VERY DIFFICULT TO SLIDE. 75% OF THE STENT DEPLOYED IN THE SFA AND THE OTHER 25% WAS CAUGHT UP IN THE SHAFT AND DRAGGED ACROSS THE POPLITEAL AND TIBIAL VESSELS WHERE IT WAS DEPLOYED. THE DISTAL END OF THE STENT WAS PLACED ACCURATELY IN THE CORRECT AREA BUT DURING DEPLOYMENT THE PROXIMAL PORTION OF THE STENT ELONGATED AND EXCEEDED THE TARGET AREA FOR DEPLOYMENT IN THE LESION. RESISTANCE WAS NOTED DURING DEPLOYMENT. A SECOND STENT WAS NOT USED OR NEEDED TO COVER THE LESION. THE ORIGINAL STENT USED COVERED THE LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE LESION WAS MEASURED TO BE 6MM IN DIAMETER. THE LESION HAD MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTUOSITY. THE LESION HAD A 95% S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325822 ↗
• MalfunctionJun 29, 2023Defective Component; Defective Component

  AS REPORTED, THE MARKERS OF A 10MM X 100MM 80CM BILIARY SMART FLEX SES (SELF-EXPANDING STENT) DELIVERY SYSTEM WERE NOT ABLE TO BE VISUALIZED UNDER FLUOROSCOPY. THE MARKERS WERE NOT MISSING. THE DEVICE DID GO INSIDE THE PATIENT. BECAUSE OF THE INABILITY TO SEE THE MARKERS, THE STENT WAS NOT DEPLOY. THE DEVICE DID GO INSIDE THE PATIENT. A NON-CORDIS STENT WAS USED AS REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY. THE COMPLAINT DEVICE WAS DISCARDED, THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL EVENT DETAILS WERE REQUESTED, HOWEVER, NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231939 ↗
• InjuryJun 23, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE CATHETER SHAFT OF A SMART FLEX 6X60 SELF-EXPANDING STENT DELIVERY SYSTEM SNAPPED WHILE BEING DELIVERED TO THE TREATMENT SITE CAUSING ¿GEOGRAPHIC MISS¿ WITH THE STENT AS IT HAD TO BE DEPLOYED PREMATURELY TO AVOID RISK TO PATIENT. THE DEPLOYMENT SHAFT DISTAL TO THE TUOHY-BORST WAS KINKED/BENT RESULTING IN INABILITY TO ADVANCE THE STENT AND NECESSITY OF DEPLOYMENT WHERE IT WAS CURRENTLY. THE TOTALITY OF THE LESION WAS NOT COVERED BY THE STENT, AS IT SHOULD HAVE BEEN. A SECOND STENT WAS THEN PLACED TO COVER THE REST OF THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MINIMAL RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. THE DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. MODERATE DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THE INTENDED PROCEDURE WAS REPORTED TO BE STENTING OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS REPORTED AS A RECALCITRANT PLAQUE IN THE SFA. THE LESION WAS NOT CALCIFIED AND NOT TORTUOUS. THE DEVICE WAS STORED, HANDLED, AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU) WITH NO DIFFICULTY IN PREPPING THE DEVICE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192898 ↗
• MalfunctionJun 10, 2023Crack; Crack

  AS REPORTED, THE PHYSICIAN WAS UNABLE TO DEPLOY THE 6MM X 40 MM 120 CM BILIARY SMART FLEX SES (SELF-EXPANDING STENT) DELIVERY SYSTEM USING PIN AND PULL. THE STENT WAS IN POSITION AND DEPLOYMENT WAS ATTEMPTED FIVE (5) TIMES, BUT THE STENT WOULD NOT DEPLOY; THE OUTER SHEATH WOULD NOT RETRACT. THE PHYSICIAN SAID THE SYSTEM WAS BREAKING WHERE THE TUOHY VALVE MEETS THE SHAFT. THE ENTIRE SYSTEM WAS REMOVED INTACT FROM PATIENT AND THERE WAS NO HARM TO THE PATIENT. ANOTHER SMART CONTROL (6X60) WAS USED AS REPLACEMENT. THE INTENDED PROCEDURE WAS REPORTED TO BE A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) STENTING. VESSEL CHARACTERISTICS INCLUDED MODERATE CALCIFICATION, MILD TORTUOSITY, SEVENTY-FIVE PERCENT STENOSIS, WITH NO ACUTE ANGLE OR BIFURCATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE AND NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ANOMALIES NOTED. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102182 ↗
• MalfunctionMay 10, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN DEPLOYING A SMART FLEX 8MM X150 MM BILIARY STENT, THE SHAFT OF THE DELIVERY SYSTEM "SHEARED OFF"; THE COVERING ON THE STENT SHAFT WAS BUNCHED UP. THERE WAS NO REPORTED PATIENT INJURY. THE ACCESS SITE WAS FEMORAL. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL CHARACTERISTICS AT TARGET SITE INCLUDED CALCIFICATION, NO TORTUOSITY AND NINETY-FIVE PER CENT STENOSIS. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING NOR DIFFICULTY NOTED DURING PREP. THE GUIDEWIRE WAS PREPPED BEFORE LOADING ON THE DEVICE. THERE WAS NO RESISTANCE WHEN ADVANCING THROUGH THE SHEATH AND NO UNUSUAL FORCE USED DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906792 ↗
• MalfunctionApr 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 6MM X 150 MM 120 CM BILIARY SMART FLEX SES (SELF-EXPANDING STENT) DELIVERY SYSTEM DID NOT FULLY DEPLOY. THE PULL AND PIN DELIVERY SYSTEM WERE PERFORMED UNTIL THE LAST 20-30MM OF THE PROXIMAL END OF THE STENT, AND IT WOULD NOT DEPLOY FURTHER. THE STENT AND SYSTEM WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. SLIGHT RESISTANCE/FRICTION WAS FELT DURING INSERTION OF THE DEVICE. THE STENT DELIVERY SYSTEM PASSED THROUGH ACUTE BENDS. THE DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS A SLIGHT DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THE INTENDED PROCEDURE WAS REPORTED TO BE A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. THE TARGET LESION WAS THE SFA WITH NO CALCIFICATION. VESSEL TORTUOSITY WAS DESCRIBED AS "TOUGH" TO GET UP AND OVER THE BIFURCATION. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835808 ↗
• MalfunctionApr 7, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 5X40 SMART FLEX BIL WAS REMOVED FROM PACKAGING AND FOUND TO HAVE PART OF THE STENT ALREADY PARTIALLY DEPLOYED/STICKING OUT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGED NOTED TO THE PRODUCT PACKAGING. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704801 ↗
• MalfunctionJan 9, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE STENT OF A 6X150 120CM BILIARY SMART FLEX SELF-EXPANDING STENT (SES) DELIVERY SYSTEM OPENED UP BUT COULD NOT BE DEPLOYED AND GOT DISLODGED. ABOUT 1/3 OF THE STENT WAS ABLE TO BE DEPLOYED INSIDE THE PATIENT. AFTER NOT BEING ABLE TO DEPLOY THE STENT ANY FURTHER, THE PHYSICIAN INDICATED HE WAS ABLE TO PULL THE ENTIRE STENT AND CATHETER ASSEMBLY INTO THE 6FR NON-CORDIS SHEATH HE HAD PARKED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THEN, THE ENTIRE SHEATH WAS REMOVED WITH THE STENT INSIDE COMPLETELY OUT OF THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMART FLEX. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE TEMP INDICATOR DID NOT SHOW ANY UNUSUAL DETAILS AND WAS VISIBLE. THERE WERE ABSOLUTELY NO SIGNS OF FAULTY ON THE DEVICE. WHEN REMOVED FROM THE TRAY, THE STENT WAS INTACT AND COVERED WITH AN OUTER SHEATH. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE LESION WAS NOT CALCIFIED NOR TORTUOUS. THERE WAS NO RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO CROSS THE LESION. THE STENT FAILED INSIDE THE VESSEL AT THE TARGET AREA WHEN IT WAS DEPLOYED. THE STENT WAS STIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128178 ↗
• InjuryOct 18, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE SMART FLEX 5X40 DELIVERY SYSTEM DID NOT DE-SHEATH THE STENT CORRECTLY, THE STENT BEGINS TO FLOWER OPEN AND THEN STOPS. IT WAS NOT A SMOOTH DELIVERY OR SHOWING ITS FULLY DEPLOYED RADIOGRAPHICALLY WHILE STENT DEPLOYMENT STENTS HAVE BEEN FINISHED. THE STENT HAD PARTIALLY DEPLOYED DISTALLY AT FIRST. THE STENT WAS FULLY DEPLOYED/OPENED AFTER PIN AND PULL PROCESS. AFTER MANY SECONDS, THE STENT FULLY DEPLOYED/OPENED BUT IT WAS NOT WHERE IT WAS SUPPOSED TO BE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INJURY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER BEING REMOVED FROM THE TRAY. THE STOPCOCK WAS NOT CONNECTED TO THE Y-CONNECTOR OF THE TUOHY BORST VALVE. THERE WAS NO DIFFICULTY WHILE FLUSHING THE SDS. THE TARGET LESION DIAMETER WAS MEASURED TO BE 4MM. THE LES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621783 ↗
• MalfunctionJul 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  AS REPORTED, THE SMART FLEX STENT DEPLOYED IN SUCH A WAY THAT IT DID NOT EXPAND. A SABER THAT WILL BE INCLUDED WITH THE STENT WAS THEN USED TO POST DILATE AND THE STENT STUCK ON THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989430 ↗

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