SentrantRecalls & reported problems across all models

We found 21 models of Sentrant by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2017 and Sep 10, 2026 — classified as 24 deaths, 21 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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

Most reported Sentrant problems

Sentrant models

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

• Sentrant™ SENSH1428W

  INTRODUCER, CATHETER
  7 deaths14 reports
• Sentrant™ SENSH1828W

  INTRODUCER, CATHETER
  3 deaths9 reports
• Sentrant™ SENSH1628W

  INTRODUCER, CATHETER
  4 deaths7 reports
• Sentrant™ SENSH2028W

  INTRODUCER, CATHETER
  3 deaths6 reports
• Sentrant™ SENSH2228W

  INTRODUCER, CATHETER
  1 death4 reports
• Sentrant™ SENSH1428W

  Introducer, catheter
  2 deaths4 reports
• Sentrant™ SENSH1628W

  Introducer, catheter
  4 reports
• Sentrant™ SENSH1628W

  INTRODUCER, CATHETER
  2 deaths3 reports
• Sentrant™ SENSH2028W

  INTRODUCER, CATHETER
  3 reports
• Sentrant™ SENSH1228W

  INTRODUCER, CATHETER
  3 reports
• Sentrant™ SENSH2228W

  INTRODUCER, CATHETER
  1 death3 reports
• Sentrant™ SENSH2428W

  INTRODUCER, CATHETER
  2 reports
• Sentrant™ SENSH2428W

  INTRODUCER, CATHETER
  1 death2 reports
• Sentrant™ SENSH1428W

  INTRODUCER, CATHETER
  1 report
• Sentrant™ SENSH1828W

  INTRODUCER, CATHETER
  1 report
• Sentrant™ SENSH1264W

  INTRODUCER, CATHETER
  1 report
• Sentrant™ SENSH1828W

  Introducer, catheter
  1 report
• Sentrant™ SENSH2028W

  Introducer, catheter
  1 report
• Sentrant™ SENSH2428W

  Introducer, catheter
  1 report
• Sentrant™ SENSH2664W

  Introducer, catheter
  1 report
• Sentrant™ SENSH1628W

  Introducer, catheter
  1 report

Recent Sentrant adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719484 ↗
• MalfunctionJun 12, 2026Material Deformation

  A SENTRANT SHEATH WAS USED AS A CONDUIT DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE, WHEN THE SENTRANT SHEATH WAS INTRODUCED INTO THE PATIENT'S FEMORAL INLINE, THERE WAS A FAILURE AT THE TIP OF THE SENTRANT WHICH MADE DEVICE NAVIGATION IMPOSSIBLE. A REPLACEMENT SENTRANT FROM THE SAME BATCH THAT HAD NO DEFECTS WAS USED AND THE TREATMENT PROCEEDED AS EXPECTED. THE CAUSE WAS NOT REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482777 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  AN ETBF2813C124EJ STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 63MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT HAD BARE-METAL STENTS PLACED FROM BOTH CIAS TO THE EIAS, WITH THE EIA OCCLUDED. ALTHOUGH STENOSIS WAS OBSERVED IN THE LEFT ACCESS, IT WAS DETERMINED THAT EVAR COULD PROCEED IF PTA WAS PERFORMED FIRST. AFTER APPLYING A 6MM PTA BALLOON TO THE LEFT ACCESS, AN ATTEMPT WAS MADE TO ADVANCE THE ETBF2813C124EJ FROM THE RIGHT ACCESS, BUT IT GOT STUCK AROUND THE CIA AND WAS DIFFICULT TO ADVANCE. IT WAS EVENTUALLY ADVANCED, AND THE MAIN BODY WAS DEPLOYED. AN NON-MEDTRONIC LIMB WAS PLACED ON THE CONTRALATERAL SIDE, DEPLOYED UP TO THE MAIN BODY ON THE IPSILATERAL SIDE, AND THEN REMOVED. DURING REMOVAL, ACCESS DAMAGE WAS A CONCERN, SO BLOOD PRESSURE WAS MONITORED. ALTHOUGH IT DROPPED SLIGHTLY, THE REPLACEMENT OF A SENTRANT SHEATH MADE IT UNCLEAR WHETHER DAMAGE HAD OCCURRED. AN NON-MEDTRONIC LIMB WAS PLACED ON THE IPSILATERAL DISTAL SIDE AND A TOUCH-UP WAS PERFORMED. FINAL ANGIOGRAPHY CONFIRMED THE ABSENCE OF ANY ENDOLEAK. A NON-MEDTRONIC SHEATH WAS INSERTED INTO THE LEFT FA WAS LOWERED TO THE FEMORAL HEAD AREA, AND ANGIOGRAPHY REVEALED A LOCALIZ

  Patient problems: Perforation of Vessels

  MAUDE report 24176301 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SENTRANT SHEATHS WERE USED AS A CONDUIT DURING A TAVI PROCEDURE . IT WAS NOTED THAT THE PATIENT PRESENTED WITH BORDERLINE DIAMETERS AND SEVERE CALCIFICATION IN REGIONS OF THE RIGHT AND LEFT COMMON ILIAC ARTERIES, AND THE RIGHT AND LEFT COMMON FEMORAL ARTERIES. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TREATMENT OF THE COMMON ILIAC AND RIGHT COMMON FEMORAL ARTERIES WAS PERFORMED. SUBSEQUENTLY, THE 26 FX VALVE (LOT K128644) WAS MOUNTED ON THE DELIVERY SYSTEM (LOT 12526098), WITH SATISFACTORY FLUOROSCOPIC VERIFICATION. PRE-DILATION WAS PERFORMED WITH A 18 X 40 NON-MEDTRONIC BALLOON. DURING THE ATTEMPT TO INSERT THE DELIVERY SYSTEM THROUGH THE RIGHT COMMON FEMORAL ARTERY, IT WAS OBSERVED THAT, DUE TO SEVERE CALCIFICATION, THERE WAS NO PROGRESSION OF THE SYSTEM. SEQUENTIAL DILATION OF THE ARTERY WAS THEN PERFORMED WITH SENTRANT 12 FR, A 14 FR NON-MEDTRONIC DEVICE , AND SENTRANT 16 FR INTRODUCERS. HOWEVER, EVEN AFTER THE DILATIONS, THE DELIVERY SYSTEM DID NOT PROGRESS. SHORTLY AFTER, THE PATIENT PRESENTED WITH BLEEDING IN THE REGION OF THE RIGHT COMMON FEMORAL ARTERY AND HYPOTENSION, DUE TO VESSEL PERFORATION. ANGIOPLASTY WITH A 7X50 COVERED STENT WAS PERFORMED, FOLLOWED BY POS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 23521903 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT, THE SHEATH SENSH1428W SENTRANT HYDRO EXPERIENCED A SHEATH VALVE DETACHMENT WHEN THE VALVE CAME OFF WITH THE DILATOR, RESULTING IN BACKFLOW OF BLOOD. THE DEVICE WAS REPLACED WITH A NEW SHEATH. THE SENTRANT WAS USED AS PER INSTRUCTIONS FOR USE (IFU) AND APPEARED NORMAL PRIOR TO USE. THE PATIENT EXPERIENCED A BLOOD LOSS OF 750 ML AND RECEIVED A TRANSFUSION OF ONE UNIT OF BLOOD DUE TO THE BLOOD LOSS ASSOCIATED WITH THE SENTRANT SHEATH PER THE PHYSICIAN THE CAUSE OF THE DETACHMENT COULD NOT BE DETERMINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22335397 ↗
• DeathMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED IN A TAVI PROCEDURE BEFORE THE PRE-DILATION OF THE AORTIC VALVE. IT WAS NOTED THAT DUE TO SEVERE CALCIFICATION OF THE FEMORAL ILIAC PATHWAY, THE ARTERIES HAD A SMALLER DIAMETER THAN RECOMMENDED. IT WAS STATED THE VASCULAR SPECIALIST WAS AWARE OF THIS BUT STILL DECIDED TO ATTEMPT THE PROCEDURE VIA THE RIGHT FEMORAL ARTERY. DURING THE PROCEDURE, AFTER PREPARING THE PRO PLUS 23 LOT: J304417 IN D-EVPROP23-29, THE 14F SENTRANT WAS INTRODUCED INTO THE RIGHT FEMORAL ARTERY WITH DIFFICULTY. THE VASCULAR TEAM PERFORMED ANGIOPLASTY IN THE COMMON ILIAC AND RIGHT EXTERNAL ILIAC WITH A 7X40 BALLOON, PRE-DILATED THE AORTIC VALVE WITH A NON-MDT 18X40 BALLOON. THE 14F SENTRANT WAS REMOVED AND THE VASCULAR TEAM WAS UNABLE TO PROGRESS WITH THE VALVE DELIVERY SYSTEM THROUGH THE RIGHT FEMORAL ARTERY, SO A NEW ANGIOPLASTY WAS PERFORMED WITH A 7X120 BALLOON IN THE COMMON AND EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. AFTER IMAGE CONTROL, THE DOCTORS SHOWED BLOOD EXTRAVASATION IN THE EXTERNAL ILIAC AND FEMORAL ARTERY AND SEVERE HYPOTENSION. A 7X58 COVERED STENT WAS IMPLANTED IN THE EXTERNAL ILIAC, AND OPEN BYPASS SURGERY WITH GRAFT WAS CHOSEN. THE PATIENT WAS TREATED WITH

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 22060802 ↗
• InjuryApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR INVOLVING A SENTRANT SHEATH, THE SIDE PORT FELL OFF, CAUSING BLEEDING FROM THE PORT. AFTER THE SHEATH WAS REMOVED, THE WIRE ACCESS WAS LOST, RESULTING IN A DELAY OF TREATMENT AND NECESSITATING MANUAL PRESSURE TO BE APPLIED TO THE SITE. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT AND BROUGHT BACK TO THE CATHETER LAB 2 DAYS LATER TO FINISH THE EVAR PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21771597 ↗
• MalfunctionApr 1, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A THORACIC AORTIC ENDOVASCULAR ISOLATION PROCEDURE, THE SENTRANT VASCULAR INTRODUCER SHEATH COULD NOT PASS THROUGH THE THORACIC AORTA STENT. THERE WAS DIFFICULTY IN WITHDRAWING THE STENT DELIVERY DEVICE WHICH WAS NOTED TO BE 24F IN DIAMETER, AND AN OBVIOUS CREASE WAS THEN OBSERVED ON THE SHEATH WHILE IN VITRO. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO WITHDRAW THE STENT DELIVERY DEVICE, WHICH WAS CHALLENGING. AFTER FORCEFULLY PULLING THE THORACIC AORTIC STENT DELIVERY SYSTEM OUT OF THE SENTRANT SHEATH, THE STENT WAS SUCCESSFULLY DELIVERED USING A NON-MEDTRONIC LARGE SHEATH, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SENTRANT SHEATH ITSELF WAS NOT NOTED TO BE DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO DAMAGE NOTED ON THE DEVICE OR PACKAGING DURING PREP AND/OR UNBOXING. THE CAUSE OF THE CREASE ON THE SHEATH COULD NOT BE DETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736803 ↗
• DeathJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH (SENSH1428W) WAS INTENDED TO BE USED AS A CONDUIT DURING A TAVI PROCEDURE. IT WAS NOTED THAT THE SENTRANT SHEATH WAS FREE FROM ANY DEFECTS. THE PATIENT PRESENTED WITH HYPOTENSION AND PERICARDIAL EFFUSION IT WAS REPORTED DURING THE INDEX PROCEDURE, THAT THE MEDICAL TEAM INADVERTENTLY PERFORATED THE LEFT VENTRICLE WHILE POSITIONING THE GUIDE WITHIN THE VENTRICLE. DESPITE EFFORTS, INCLUDING CARDIORESPIRATORY RESUSCITATION AND PERICARDIAL DRAINAGE, THE INTERVENTIONS WERE UNSUCCESSFUL, AND THE PATIENT EXPIRED DURING THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE PERFORATION AND SUBSEQUENT DEATH WAS DUE TO USER ERROR.

  Patient problems: Insufficient Information

  MAUDE report 21079100 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A 16F SENTRANT SHEATH ((B)(6)) WAS INTENDED TO BE USED AS A CONDUIT DURING AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE SHEATH WAS PLACED IN THE PATIENT AND UPON REMOVAL OF THE DILATOR, THE SENTRANT SHEATH MALFUNCTIONED, LEADING TO SIGNIFICANT BLOOD LOSS, THOUGH NO PATIENT INJURY OCCURRED. NO DAMAGE WAS OBSERVED ON THE SHEATH ITSELF, BUT SLIGHT DAMAGE AND BEND TO THE WAS NOTED. THE 16F SHEATH WAS REPLACED FOR A NEW SHEATH, WHICH SUCCESSFULLY CONTROLLED THE BLEEDING. THE IFU WAS FOLLOWED WHEN USING THE SENTRANT. PER THE PHYSICIAN THE CAUSE HEMOSTATIC VALVE LEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576347 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF 1 61MM AAA . A 20FR SENTRANT SHEATH WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE 2 VALIANT CAPTIVIA STENT GRAFTS WERE DELIVERED DIRECTLY WITHOUT THE USE OF A INTRODUCER SHEATH. A SENTRANT SHEATH WAS USED TO BACK-FILL. POST BALLOONING AND DURING THE FINAL RUN, THE SENTRANT SHEATH WITHDREW FROM THE AORTA. PRIOR TO THE PHYSICIAN GAINING CONTROL THE PATIENT LOST APPROX. 1000CC OF BLOOD BEFORE THE PHYSICIAN REGAINED HEMOSTATIC CONTROL. THE PHYSICIAN CLOSED THE AORTA AND 3 UNITS OF BLOOD WERE GIVEN TO THE PATIENT. THE PATIENT WAS FOLLOWING COMMANDS, MOVING BOTH FEET, AND HAD DOPPLER SIGNALS, AND GOOD URINE OUTPUT POST PROCEDURE. IT WAS CONFIRMED THE VALIANT STENT GRAFTS DID NOT CAUSE OR CONTRIBUTE TO THE BLOOD LOSS AND THERE IS NO ALLEGATION AGAINST THEM. THE SENTRANT SHEATH DID LEAD TO THE BLOOD LOSS DUE TO BEING WITHDRAWN PREMATURELY, IT WAS WITHDRAWN PREMATURELY DUE TO THE AREA BEING CONFINED AND AN INABILITY TO VISUALIZE THE SHEATH. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20555133 ↗
• MalfunctionAug 2, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  A SENTRANT SHEATH (B)(6) WAS USED AS A CONDUIT DURING AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, WHEN INTRODUCING THE SHEATH INTO THE PATIENT, THE VALVE CAME LOOSE, CAUSING A LEAK FROM VALVE. THE SENTRANT SHEATH WAS REPLACED WITH AN ALTERNATIVE MEDTRONIC SENTRANT SHEATH (00182574) OF THE SAME SIZE, AND PROCEDURE CONTINUED SUCCESSFULLY WITHOUT FURTHER ISSUE. PER THE PHYSICIAN THE CAUSE HEMOSTASIS VALVE LEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19891955 ↗
• MalfunctionJul 2, 2024Material Deformation; Material Deformation

  A SENTRANT SHEATH WAS INTENDED TO BE USED AS A CONDUIT DURING THE IMPLANT OF A TRANSCATHETER EVOLUT PRO PLUS 34 BIOPROSTHETIC VALVE. THE PATIENT WAS NOTED TO HAVE COMPLEX AND CALCIFIED BICUSPID ANATOMY. THE SENTRANT SHEATH WAS NOTED TO BE DAMAGED WHEN IT WAS REMOVED FROM THE PATIENT AFTER PRE-DILATATION. AS THE DAMAGE COULD CAUSE RISK TO THE PATIENT'S ARTERIES AND THE DEVICE WOULD NEED TO BE REINTRODUCED INTO THE PATIENT, A NEW SENTRANT WAS USED TO CARRY OUT THE PROCEDURE. THE CAUSE OF THE SENTRANT DAMAGE WAS NOT PROVIDED. AN INFOLD OF THE EVOLUT VALVE OCCURRED DURING THE PROCEDURE BUT IT WAS CONFIRMED THE SENTRANT SHEATH DID NOT CONTRIBUTE TO THIS EVENT. A NEW PRE-DILATION WAS PERFORMED WITH A 25 BALLOON AND THEN THE PROSTHESIS WAS IMPLANTED WITHOUT COMPLICATIONS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653810 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH ((B)(6)) WAS USED AS A CONDUIT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE. AT IMPLANT THE DIAMETER OF THE RIGHT FEMORAL ACCESS VESSEL WAS 5.92MM TORTUOUS CALCIFIED ANATOMY WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE 18FR SENTRANT SHEATH ADVANCED WITH EASE. A SERIES OF WIRE AND CATHETER EXCHANGES OCCURRED AND A PRE-DILATION WAS COMPLETED WITH A NON MDT BALLOON. WHEN THE 18FR SENTRANT WAS WITHDRAWN, THE VALVE DELIVERY SYSTEM (DCS) WAS ADVANCED BUT COULD NOT BE ADVANCED BEYOND THE EXTERNAL ILIAC. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 18FR SENTRANT BUT WAS UNABLE TO ADVANCE BEYOND THE EXTERNAL ILIAC. AN ANGIOSCAN REVEALED A DISSECTION IN THE RIGHT EXTERNAL ILIAC. A BALLOON WAS PLACED FOR HEMOSTASIS AND A NON MDT STENT PLACED. THE TAVR PORTION OF THE PROCEDURE WAS ENDED. PER THE PHYSICIAN THE DISSECTION WAS CAUSED BY PATIENT ANATOMY DUE TO THE PATIENT'S TORTUOUS AND CALCIFIED ANATOMY AND THE INTRODUCTION OF THE EXTERNAL SHEATH WHICH PREVENTED THE DELIVERY SYSTEM FROM BEING ADVANCED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 19095288 ↗
• MalfunctionMar 28, 2024Material Deformation; Material Deformation

  A SENTRANT SHEATH WAS INTENDED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED THAT DURING THE PREPARATION STAGE, IT WAS SEEN THAT THE TAPERED TIP OF THE SHEATH WAS BENT. THE ISSUE WAS NOTED AS THE DEVICE WAS TAKEN OUT OF THE BOX. THE SHEATH WAS THEREFORE NOT USED. A NEW SHEATH WAS OPENED. IT WAS CONFIRMED THE BOX AND PACKAGING WERE IN NORMAL CONDITION. PER THE PHYSICIAN THE CAUSE OF THE DEFORMATION WAS  A FAULTY SHEATH.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE DEVICE WAS NEVER USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995225 ↗

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