Bard® Minnesota Four Lumen Tube 0092220Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741076824), received between Mar 2, 2018 and Sep 18, 2026 — classified as 1 death, 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 17, 2025Class IOpen, Classified

   Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

   Z-1755-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823233 ↗
• InjuryJul 15, 2026Separation Failure

  IT WAS REPORTED BY CUSTOMER THAT THE ESOPHAGEAL TAMPONADE TUBE WAS UNABLE TO REMOVE THE PLASTIC PLUGS SO THE TUBE COULD BE FULLY ASSEMBLED AND IMMEDIATELY AVAILABLE FOR USE DURING A LIFE-THREATENING VARICEAL HEMORRHAGE, DOING SO UNDER CLEAN PROCESS IN CENTRAL PROCESSING TO BE WRAPPED AND STERILIZED POST ASSEMBLY. BECAUSE THIS DEVICE WAS EXTREMELY TIME-INTENSIVE TO ASSEMBLE IN AN EMERGENCY, THEY MADE THE DECISION TO HAVE IT PREASSEMBLED UNDER CENTRAL PROCESSING BY A PHYSICIAN SO IT COULD BE DEPLOYED WITHOUT DELAY. DESPITE FOLLOWING THE MANUFACTURER'S RECALL INSTRUCTIONS, OUR PHYSICIAN SPENT APPROXIMATELY ONE HOUR TRYING TO REMOVE THE PLASTIC PLUGS WITHOUT SUCCESS. FRANKLY, THEY DISCOVERED THIS DEFECT ONLY BY CHANCE DURING OUR PREPAREDNESS PROCESS. HAD THIS FIRST BEEN ENCOUNTERED DURING AN ACTUAL EMERGENCY, THE DEVICE WOULD HAVE BEEN UNUSABLE WHILE A PATIENT WAS ACTIVELY BLEEDING. THAT REPRESENTS A SIGNIFICANT PATIENT SAFETY CONCERN. 2 SERIOUS INJURIES AND 1 DEATH HAVE ALREADY BEEN ASSOCIATED WITH THIS ISSUE.

  Patient problems: Insufficient Information; Unspecified Gastrointestinal Problem

  MAUDE report 25825240 ↗
• MalfunctionJul 15, 2026Separation Failure

  IT WAS REPORTED BY CUSTOMER THAT THE ESOPHAGEAL TAMPONADE TUBE WAS UNABLE TO REMOVE THE PLASTIC PLUGS SO THE TUBE COULD BE FULLY ASSEMBLED AND IMMEDIATELY AVAILABLE FOR USE DURING A LIFE-THREATENING VARICEAL HEMORRHAGE, DOING SO UNDER CLEAN PROCESS IN CENTRAL PROCESSING TO BE WRAPPED AND STERILIZED POST ASSEMBLY. BECAUSE THIS DEVICE WAS EXTREMELY TIME-INTENSIVE TO ASSEMBLE IN AN EMERGENCY, THEY MADE THE DECISION TO HAVE IT PREASSEMBLED UNDER CENTRAL PROCESSING BY A PHYSICIAN SO IT COULD BE DEPLOYED WITHOUT DELAY. DESPITE FOLLOWING THE MANUFACTURER'S RECALL INSTRUCTIONS, OUR PHYSICIAN SPENT APPROXIMATELY ONE HOUR TRYING TO REMOVE THE PLASTIC PLUGS WITHOUT SUCCESS. FRANKLY, THEY DISCOVERED THIS DEFECT ONLY BY CHANCE DURING OUR PREPAREDNESS PROCESS. HAD THIS FIRST BEEN ENCOUNTERED DURING AN ACTUAL EMERGENCY, THE DEVICE WOULD HAVE BEEN UNUSABLE WHILE A PATIENT WAS ACTIVELY BLEEDING. THAT REPRESENTS A SIGNIFICANT PATIENT SAFETY CONCERN. 2 SERIOUS INJURIES AND 1 DEATH HAVE ALREADY BEEN ASSOCIATED WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825237 ↗
• MalfunctionFeb 4, 2026Separation Failure

  IT WAS REPORTED THAT THEY RAN INTO AN ISSUE WITH THE LUMENS AND THE PLASTIC CAPS THAT SHOULD BE REMOVAL. THEY DID NOT GET THE PLASTIC CAPS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259542 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAKAGE AT THE CONNECTION BETWEEN THE ESOPHAGUS BALLOON AND THE 3WAY VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480135 ↗
• MalfunctionAug 27, 2025Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE INCIDENT HAPPENED TO THEM WHEN THEY PUT DOWN THE BLAKEMORE FOR FEW MONTHS AGO. WAS VERY DIFFICULT TO PULL OUT THE STOPPERS, HAD TO USE A SET OF CLAMPS FROM THE PROCEDURE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904275 ↗
• MalfunctionAug 25, 2025Defective Component; Separation Failure; Defective Component; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY HAVE ISSUE WITH MINNESOTA TUBE PLUGS ADDRESSED ON 2 TUBES AT THEIR FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884262 ↗
• MalfunctionMay 19, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER USED ONE OF THESE SPECIALTY TUBES AND CATHETERS A COUPLE OF WEEKS AGO NOT FOR A PATIENT FOR EDUCATIONAL PURPOSES AND IT WAS VERY HARD TO TAKE THE PLUGS OUT. REMOVED THEM FROM THE TUBES IN THE EMERGENCY DEPARTMENT EARLIER THIS WEEK AND THOSE PLUGS WERE A NIGHTMARE TO GET OUT. THOUGH TAKING THEM OUT NOW WILL DECREASE TIME SPENT ON THIS PATIENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044230 ↗
• InjuryMar 20, 2025Separation Failure; Defective Device; Separation Failure; Defective Device

  IT WAS REPORTED THAT 7 INTENSIVE CARE UNIT (ICU) MALFUNCTION WHILE USING MINNESOTA TUBE. PER FOLLOW UP RESPONSE RECEIVED ON 31DEC2024, CUSTOMER STATED MULTIPLE PRODUCTS WERE USED AND TIME WAS WASTED. THE PATIENT WAS BLEEDING AND NEEDED THE DEVICE TO HELP TAMPONADE THE BLEED SO THE PATIENT COULD GO TO INTERVENTIONAL RADIOLOGY (IR). THE DEVICE WAS REPLACED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21652715 ↗
• MalfunctionMar 10, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THEY WERE ASKED TO PULL ALL OF THIS ESOPHAGEAL TAMPONADE TUBE AND CHECKED TO SEE IF THE CONNECTERS WERE STUCK OR CRUMBLING. THE CONNECTORS ON THIS ONE WERE STUCK IN TIGHTLY AND THEY COULD NOT REMOVE ANY OF THEM. PER FOLLOW UP VIA EMAIL ON 07-FEB-2025, THE INVENTORY CONTROLLER STATED AS FAR AS SHE KNEW, THE DEVICE WAS NOT USED ON A PATIENT. CONFIRMED DEVICE WAS MATERIAL # 0092220 AND PROVIDED LOT # MCJN2679 AND LOT # MCJR1392. BOTH DEVICES HAVE WHITE PLUGS THAT CANNOT BE REMOVED. PER FOLLOW UP EMAIL RECEIVED ON 19-FEB-2025, THE INVENTORY CONTROLLER REPORTED THAT SHE ORDERED NEW MINNESOTA TUBE DEVICES LOT # MCJQ1715 AND THEY ARE ALSO COMING IN WITH THE PLUGS STUCK AND CANNOT BE REMOVED. SHE ADDITIONALLY CONFIRMED THE DEVICES HAVE NOT BEEN USED ON ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558746 ↗
• MalfunctionFeb 25, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THEY WERE ASKED TO PULL ALL OF THIS ESOPHAGEAL TAMPONADE TUBE AND CHECKED TO SEE IF THE CONNECTERS WERE STUCK OR CRUMBLING. THE CONNECTORS ON THIS ONE WERE STUCK IN TIGHTLY AND THEY COULD NOT REMOVE ANY OF THEM. PER FOLLOW UP VIA EMAIL ON 07-FEB-2025, THE INVENTORY CONTROLLER STATED AS FAR AS SHE KNEW, THE DEVICE WAS NOT USED ON A PATIENT. CONFIRMED DEVICE WAS MATERIAL#: 0092220 AND PROVIDED LOT#: MCJN2679 AND LOT#: MCJR1392. BOTH DEVICES HAVE WHITE PLUGS THAT CANNOT BE REMOVED. PER FOLLOW UP EMAIL RECEIVED ON 19-FEB-2025, THE INVENTORY CONTROLLER REPORTED THAT SHE ORDERED NEW MINNESOTA TUBE DEVICES LOT#: MCJQ1715 AND THEY ARE ALSO COMING IN WITH THE PLUGS STUCK AND CANNOT BE REMOVED. SHE ADDITIONALLY CONFIRMED THE DEVICES HAVE NOT BEEN USED ON ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462223 ↗
• MalfunctionFeb 5, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THEY WERE ASKED TO PULL ALL OF THIS ESOPHAGEAL TAMPONADE TUBE AND CHECKED TO SEE IF THE CONNECTERS WERE STUCK OR CRUMBLING. THE CONNECTORS ON THIS ONE WERE STUCK IN TIGHTLY AND THEY COULD NOT REMOVE ANY OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312085 ↗
• MalfunctionFeb 3, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  IT WAS REPORTED THAT 4 AREAS ON THIS MINNESOTA TUBE THAT HAVE A PLUG THAT WAS STUCK. THE PLUGS CANNOT BE REMOVED AS DESIGNED - MULTIPLE STAFF HAVE TRIED AND BEEN UNABLE TO REMOVE THEM. SINCE THIS WAS A PRODUCT THAT WAS USED ONLY IN AN EMERGENCY, THE INABILITY TO USE IT PROPERLY COULD VERY EASILY CAUSE PATIENT HARM OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291086 ↗
• MalfunctionJan 3, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER ASKED TO PULL ALL OF THIS ESOPHAGEAL TAMPONEAL TUBE AND CHECKED TO SEE IF THE CONNECTOR WERE STUCK OR CRUMBLING ETC. THE CONNECTOR ON THIS ONE WERE STUCK IN TIGHTLY AND THEY COULD NOT REMOVE OF THEM. PER FOLLOW UP VIA PHONE ON 13DEC2024, IT WAS REPORTED THAT THE CUSTOMER HAD ONE KIT WITH ONLY TWO OF THE CONNECTORS THAT WOULD COME OFF AND TWO NEW KIT NONE OF THE CONNECTORS WOULD COME OFF. THEY WERE ON THERE TIGHT AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066582 ↗
• MalfunctionJan 2, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER ASKED TO PULL ALL OF THIS ESOPHAGEAL TAMPONEAL TUBE AND CHECKED TO SEE IF THE CONNECTOR WERE STUCK OR CRUMBLING ETC. THE CONNECTOR ON THIS ONE WERE STUCK IN TIGHTLY AND THEY COULD NOT REMOVE OF THEM . PER FOLLOW UP VIA PHONE ON 13DEC2024, IT WAS REPORTED THAT THE CUSTOMER HAD ONE KIT WITH ONLY TWO OF THE CONNECTORS THAT WOULD COME OFF AND TWO NEW KIT NONE OF THE CONNECTORS WOULD COME OFF. THEY WERE ON THERE TIGHT AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055277 ↗
• MalfunctionDec 11, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER ASKED TO PULL ALL OF THIS ESOPHAGEAL TAMPONEAL TUBE AND CHECKED TO SEE IF THE CONNECTOR WERE STUCK OR CRUMBLING ETC.THE CONNECTOR ON THIS ONE WERE STUCK IN TIGHTLY AND THEY COULD NOT REMOVE OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901930 ↗
• MalfunctionDec 10, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE THERE WERE FOUR AREAS ON THIS ESOPHAGEAL TAMPONADE TUBE THAT HAVE A PLUG THAT WAS STUCK. THE PLUGS COULD NOT BE REMOVED AS DESIGNED - MULTIPLE STAFF HAVE TRIED AND BEEN UNABLE TO REMOVE THEM. SINCE THIS WAS A PRODUCT THAT WAS USED ONLY IN AN EMERGENCY, THE INABILITY TO USE IT PROPERLY COULD VERY EASILY CAUSED PATIENT HARM AND/OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891928 ↗
• MalfunctionDec 9, 2024Separation Failure; Material Split, Cut or Torn; Separation Failure; Material Split, Cut or Torn

  IT WAS REPORTED THAT PLASTIC CAPS ADHERED TO THE RUBBER OF THE MINNESOTA TUBE, RIPPING OFF SECTIONS OF THE TUBE ONCE ABLE TO PULL OFF AFTER 15 MINUTES AND 4 PEOPLE. NOT EXPIRED. CHECKED A NEW TUBE, WHICH HAD THE SAME ISSUE. NOT AN OK ISSUE IN A CRITICAL LIFE-SAVING EVENT. CUSTOMER EXPERIENCED THIS ISSUE WITH 3 TUBES. THEY HAD 2 TUBES REMAINING IN INVENTORY. THEY COULD RETURN THE TWO FAILED TUBES THAT WERE NOT USED ON THE PATIENT. THE PATIENT EXPIRED. TUBES WERE STORED IN THE CLEAN UTILITY ROOM THAT WAS TEMPERATURE CONTROLLED. CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 13-NOV-2024. THE CLINICAL OPERATIONS MANAGER REPORTED THE 58-YEAR-OLD MALE WAS ADMITTED ON 08-NOV-2024 AT APPROXIMATELY 0030 DUE TO AN ACUTE UPPER GASTROINTESTINAL (GI) BLEED, WHICH REQUIRED USE OF THE MINNESOTA TUBE. DURING DEVICE SET UP, THEY WERE UNABLE TO REMOVE THE CAPS IN A TIMELY FASHION. ONCE THE CAPS WERE ABLE TO BE PRIED OFF, IT REMOVED RUBBER OF THE TUBE WITH THE CAP. THEY WERE UNABLE TO USE THE DEVICE. THE PATIENT PASSED AWAY ON 08-NOV-2024 AT 1336 DUE TO HEMORRHAGIC SHOCK DUE TO ESOPHAGEAL VARICES GASTROINTESTINAL BLEEDING (EV GIB). THE CLINICAL OPERATIONS MANAGER REPORTED THEY DISCOVERED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878627 ↗
• DeathNov 27, 2024Separation Failure; Material Split, Cut or Torn; Separation Failure; Material Split, Cut or Torn

  IT WAS REPORTED THAT PLASTIC CAPS ADHERED TO THE RUBBER OF THE MINNESOTA TUBE, RIPPING OFF SECTIONS OF THE TUBE ONCE ABLE TO PULL OFF AFTER 15 MINUTES AND 4 PEOPLE. NOT EXPIRED. CHECKED A NEW TUBE, WHICH HAD THE SAME ISSUE. NOT AN OK ISSUE IN A CRITICAL LIFE-SAVING EVENT. CUSTOMER EXPERIENCED THIS ISSUE WITH 3 TUBES. THEY HAD 2 TUBES REMAINING IN INVENTORY. THEY COULD RETURN THE TWO FAILED TUBES THAT WERE NOT USED ON THE PATIENT. THE PATIENT EXPIRED. TUBES WERE STORED IN THE CLEAN UTILITY ROOM THAT WAS TEMPERATURE CONTROLLED. CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 13-NOV-2024. THE CLINICAL OPERATIONS MANAGER REPORTED THE 58-YEAR-OLD MALE WAS ADMITTED ON (B)(6) 2024 AT APPROXIMATELY 0030 DUE TO AN ACUTE UPPER GASTROINTESTINAL (GI) BLEED, WHICH REQUIRED USE OF THE MINNESOTA TUBE. DURING DEVICE SET UP, THEY WERE UNABLE TO REMOVE THE CAPS IN A TIMELY FASHION. ONCE THE CAPS WERE ABLE TO BE PRIED OFF, IT REMOVED RUBBER OF THE TUBE WITH THE CAP. THEY WERE UNABLE TO USE THE DEVICE. THE PATIENT PASSED AWAY ON (B)(6) 2024 AT 1336 DUE TO HEMORRHAGIC SHOCK DUE TO ESOPHAGEAL VARICES GASTROINTESTINAL BLEEDING (EV GIB). THE CLINICAL OPERATIONS MANAGER REPORTED THEY DISCOVERED TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20796358 ↗
• MalfunctionNov 27, 2024Separation Failure; Material Split, Cut or Torn; Separation Failure; Material Split, Cut or Torn

  IT WAS REPORTED THAT PLASTIC CAPS ADHERED TO THE RUBBER OF THE MINNESOTA TUBE, RIPPING OFF SECTIONS OF THE TUBE ONCE ABLE TO PULL OFF AFTER 15 MINUTES AND 4 PEOPLE. NOT EXPIRED. CHECKED A NEW TUBE, WHICH HAD THE SAME ISSUE. NOT AN OK ISSUE IN A CRITICAL LIFE-SAVING EVENT. CUSTOMER EXPERIENCED THIS ISSUE WITH 3 TUBES. THEY HAD 2 TUBES REMAINING IN INVENTORY. THEY COULD RETURN THE TWO FAILED TUBES THAT WERE NOT USED ON THE PATIENT. THE PATIENT EXPIRED. TUBES WERE STORED IN THE CLEAN UTILITY ROOM THAT WAS TEMPERATURE CONTROLLED. CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 13-NOV-2024. THE CLINICAL OPERATIONS MANAGER REPORTED THE 58-YEAR-OLD MALE WAS ADMITTED ON (B)(6) 2024 AT APPROXIMATELY 0030 DUE TO AN ACUTE UPPER GASTROINTESTINAL (GI) BLEED, WHICH REQUIRED USE OF THE MINNESOTA TUBE. DURING DEVICE SET UP, THEY WERE UNABLE TO REMOVE THE CAPS IN A TIMELY FASHION. ONCE THE CAPS WERE ABLE TO BE PRIED OFF, IT REMOVED RUBBER OF THE TUBE WITH THE CAP. THEY WERE UNABLE TO USE THE DEVICE. THE PATIENT PASSED AWAY ON (B)(6) 2024 AT 1336 DUE TO HEMORRHAGIC SHOCK DUE TO ESOPHAGEAL VARICES GASTROINTESTINAL BLEEDING (EV GIB). THE CLINICAL OPERATIONS MANAGER REPORTED THEY DISCOVERED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795772 ↗
• MalfunctionJun 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ESOPHAGEAL TAMPONADE TUBE WAS IN PLACE IN PATIENT AND THE GASTRIC BALLOON LOST AIR. WHEN TUBE WAS PULLED OUT, THE GASTRIC BALLOON APPEARED TO HAVE A LARGE TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593517 ↗
• MalfunctionJun 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS IN PLACE IN PATIENT AND THE GASTRIC BALLOON LOST AIR. WHEN TUBE WAS PULLED OUT, THE GASTRIC BALLOON APPEARED TO HAVE A LARGE TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546902 ↗
• MalfunctionMay 15, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT MINNESOTA TUBE DID NOT PROPERLY DEFLATE. WAS NOT ABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321461 ↗
• MalfunctionMay 9, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THEY HAD A PRODUCT COMPLAINT ON ESOPHAGEAL TAMPONEAL TUBE. THEY STATED THERE WAS 4 BALLOON PORTS WITH WHITE PEGS. THEY SPENT ABOUT 20MINS GETTING THE PLUGS OUT OF THE PORT. ONE OF THE BALLOON NOT ABLE TO GET OUT. THIS HAS BEEN LASTING FOR A FEW MONTHS PRODUCT HAD NOT BEEN WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277380 ↗
• MalfunctionMar 12, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CUSTOMER INFLATED THE BALLOON OF THE ESOPHAGEAL TAMPONADE TUBE AND IT RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885294 ↗