Sentinel Seal 8888571562 (UDI 10884521061026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521061026), received between Apr 11, 2018 and Jul 2, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE GAUGE OF THE CONNECTOR WAS TOO SMALL AND SEVERAL CHEST TUBES HAVE ALREADY FALLEN OFF THE NEW DEVICES SEVERAL TIMES. PER CUSTOMER, THE BACK DOOR IN THE BOX OPENS EASILY AND EXPOSES THE WATER SEAL CHAMBER AND THEY ARE COMPLICATED TO USE AS A RESULT IT WAS EASILY CONTAMINATED AND NOT STERILE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658934 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE GAUGE OF THE CONNECTOR WAS TOO SMALL. SEVERAL CHEST TUBES HAVE ALREADY FALLEN OFF THE NEW DEVICES SEVERAL TIMES. PER CUSTOMER, THE BACK DOOR IN THE BOX OPENS EASILY AND EXPOSES THE WATER SEAL CHAMBER AND THEY ARE COMPLICATED TO USE AS A RESULT IT WAS EASILY CONTAMINATED AND NOT STERILE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529361 ↗
• MalfunctionApr 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN THE WALL VACUUM WAS CONNECTED, THE BLUE LIQUID CONTAINED IN THE PATIENT MANOMETER COMPARTMENT SPILLED INTO THE "UNDERWATER SAFETY" COMPARTMENT. THE TWO COMPARTMENTS BEGAN TO BUBBLE AND THE VACUUM WAS NOT CREATED. BLUE LIQUID WAS ALSO FOUND ON THE UNDERSIDE OF THE CHEST DRAINAGE UNIT (CDU). THE CDU WAS THEREFORE CHANGED AND ANOTHER CDU FROM THE SAME BATCH WAS PLUGGED IN AND WORKED WITHOUT A PROBLEM. THERE WAS NO PATIENT HARM REPORTED. THE CDU WAS NOT KEPT BECAUSE IT WAS SOILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031466 ↗
• MalfunctionOct 4, 2023Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT THE PATIENT ARRIVED POST CARDIAC PROCEDURE. NEW DRAINS (ARGYLET SENTINEL SEALT CHEST DRAIN) WERE ATTACHED TO PATIENT AND NO TRAINING WAS GIVEN TO THE BEDSIDE NURSE AND THEY WERE UNAWARE OF THE CHANGE OF THE DRAINS. THE THEATRE NURSE GAVE A SMALL HANDOVER OF HOW TO USE THE DRAIN AND TO MAKE SURE IT WAS DRAINING. THE DRAINS ARRIVED EMPTY, AND WERE MEANT TO BE BUBBLING AS PER THEATRE NURSE INSTRUCTIONS, BUT IT WAS NOT. THE DRAINS DID NOT DRAIN ANYTHING IN THE FIRST 30 MINUTES. THE NURSE IN CHARGE WAS INFORMED AND TRIED TO ADJUST THE SUCTION, THEN 400MLS DUMPED OUT OF THE DRAINS AND THE PATIENT DID NOT BECOME UNSTABLE DURING THIS EPISODE. HB (HEMOGLOBIN) WAS ALSO STABLE. THE DRAINS ONCE AGAIN STOPPED DRAINING. THE THEATRE STAFF WAS INFORMED BY THE NURSE IN CHARGE. THE THEATRE STAFF BOUGHT A REGULAR DRAIN (PLEURASEAL) AND ATTACHED THE DRAIN, STRAIGHT AWAY IT DRAINED 50MLS, AND CONTINUED TO DRAIN AFTERWARDS. PER ADDITIONAL INFORMATION RECEIVED, THEY REMOVED THE DRAIN AND REPLACED IT WITH A PLEURASEAL ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871455 ↗
• MalfunctionOct 4, 2023Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT THE PATIENT ARRIVED FROM THE THEATRE, WITH THE NEW TYPE (ARGYLE SENTINEL SEAL CHEST DRAIN) OF CHEST DRAIN. THERE WAS MINIMAL DRAINAGE FROM THE DRAIN. ONCE AGAIN, THE DRAIN WAS ATTACHED TO SUCTION, BUT THERE WERE NO BUBBLES AS PER THE NURSE'S INSTRUCTIONS. THE PDN AND NURSE MANAGER WAS AT BEDSIDE WHEN THEATRE NURSE CAME TO INSPECT DRAIN AND IT WAS STILL NOT WORKING SO IT WAS DECIDED TO CHANGE IT TO A REGULAR PLEURASEAL DRAIN. ONCE IT WAS ATTACHED AND SUCTION WAS APPLIED, THE DRAIN OUTPUTED 50MLS. PER ADDITIONAL INFORMATION RECEIVED, THEY REMOVED THE DRAIN AND REPLACED IT WITH A PLEURASEAL ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871447 ↗
• MalfunctionApr 14, 2022Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT THE ON/OFF VACUUM DIDN'T WORK ON THE DEVICE. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 7-APR-2022 STATED THAT THE ISSUE WAS FOUND PRIOR TO THE PROCEDURE. THE DEVICE DID NOT SUCTION PROPERLY. ADDITIONAL INFORMATION RECEIVED ON 8-APR-2022 STATED THAT WHEN THE USER CONNECTS THE DEVICE TO THE VACUUM SOURCE, THE SYSTEM DOES NOT WORK, THE ON/OFF BUTTON ON THE SYSTEM IS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112404 ↗
• MalfunctionMar 30, 2022Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THE DEVICE DIDN'T WORK WHEN THE VACUUM SOURCE WAS ON. THIS WAS NOTICED BEFORE USE WITH A PATIENT AND THERE WAS NO DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950162 ↗
• MalfunctionDec 15, 2021Suction Problem; Suction Problem

  THE CUSTOMER STATES THE CDU WAS LEAKING AT THE COLLECTION CHAMBER. THE TARGET VACUUM WASN'T REACHED. THIS HAPPENED DURING USE ON A PATIENT AND THERE WAS NO INJURY. THE UNIT WAS SWITCHED WITH ANOTHER WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009872 ↗
• MalfunctionApr 14, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT SHORTLY AFTER STARTED USING THE PRODUCT ON A PATIENT, IT WAS NOTICED THAT THEY HAD NOT BEEN ABLE TO PERFORM SUCTION. THE CUSTOMER FURTHER MENTIONED THAT THERE WAS A BACK-FLOW OBSERVED, SO THEY IMMEDIATELY STOPPED USING IT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664117 ↗
• MalfunctionFeb 28, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11390866 ↗
• MalfunctionFeb 28, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11390864 ↗
• MalfunctionFeb 28, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11390862 ↗
• MalfunctionFeb 22, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359318 ↗
• MalfunctionFeb 22, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359265 ↗
• MalfunctionFeb 22, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359222 ↗
• MalfunctionFeb 22, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359162 ↗
• MalfunctionFeb 22, 2021Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SUCTION FUNCTION. LIQUID FROM THE DIFFERENT CHAMBERS WERE MIXED WITH THE WATER SEAL CHAMBER. THE SYSTEM IS VERY UNSTABLE AND OVERTURNS EASILY AS IT IS HIGH AND NARROW, DESPITE THE FOOT THAT CAN BE PUT ACROSS THE BOTTOM OF THE DEVISE. THE CHAMBER WHERE STERILE WATER IS FILLED TO THE WATER TRAP, IS SPECIFIED TO CLICK WHEN CLOSED TO ENSURE PROPER AND TIGHT CLOSURE; HOWEVER, IT DID NOT CLOSE TIGHTLY. THE LACK OF CORRECT FUNCTION PROLONGS TREATMENT AND HOSPITAL STAY. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359073 ↗
• MalfunctionJul 13, 2020Suction Problem; Suction Problem

  THE CUSTOMER REPORTED A SUCTION PROBLEM WITH THE DEVICE. NEGATIVE VOID NO MAINTENANCE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 STATED THAT DEVICE WAS UNABLE TO SUCTION/ONLY HAD PARTIAL SUCTION AND THAT ¿NEGATIVE VOID NO MAINTENANCE¿ MEANS THAT THE SYSTEM WAS NOT ABLE TO KEEP A GOOD SUCTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10268428 ↗
• MalfunctionApr 11, 2018Detachment Of Device Component; Detachment Of Device Component

  CUSTOMER REPORTS THAT TUBING IS DETACHED FROM THE CHAMBER. THE LIQUID IN THE STERILE CHAMBER DOES REACH THE LEVEL MARKED IN RED. THEREFORE THE ASPIRATION IS NOT COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423188 ↗