EXPRESS 16400Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00650862164008), received between Jun 5, 2016 and Aug 12, 2026 — classified as 7 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (82 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.

   Z-1303-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225706 ↗
• MalfunctionMay 25, 2026Off-Label Use

  THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM REGARDING AN EXPRESS MINI 500 DRAIN USE AT HOME. THE PATIENT REPORTED BEING ABLE TO DRAIN FLUID OVER THE PAST SEVERAL DAYS DESPITE NOTICING CLOTS IN THE DRAINAGE AREA; HOWEVER, ON THE DAY OF THE CALL, SHE WAS UNABLE TO DRAIN ANY FLUID FROM THE PORT. THE PATIENT INQUIRED ABOUT ALTERNATE METHODS TO EMPTY THE DRAIN. SHE WAS ADVISED THAT THE DEVICE SHOULD NOT BE DISCONNECTED AS IT MAY CAUSE HARM. THE PATIENT CONFIRMED NO DISTRESS AT THE TIME OF THE CALL. WITH APPROXIMATELY 350 ML REMAINING IN THE DRAINAGE SYSTEM, THE PATIENT WAS ADVISED TO CONTACT HER PHYSICIAN FOR EVALUATION. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268565 ↗
• MalfunctionApr 28, 2026Off-Label Use

  THE COMPLAINT WAS RECEIVED VIA A DIRECT CALL TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED THAT THE PHYSICIAN INSTRUCTED THE USER TO DRAIN THE CHEST DRAIN, HOWEVER, NO FLUID COULD BE OBTAINED FROM THE PORT DESPITE A RECORDED VOLUME OF 450 ML. THE PATIENT WAS NOT SHORT OF BREATH AND SHOWED NO SIGNS OF RESPIRATORY DISTRESS. INQUIRY WAS MADE REGARDING DISCONNECTING THE CHEST DRAIN TO REMOVE THE FLUID, AND IT WAS EXPLAINED THAT THE DRAIN WOULD REQUIRE REPLACEMENT IN A HOSPITAL SETTING. THE USER WAS ADVISED TO VISIT TO THE EMERGENCY ROOM OR CONTACT THEIR PHYSICIAN. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014487 ↗
• MalfunctionMar 17, 2026Off-Label Use

  THE COMPLAINT WAS RECEIVED VIA A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. THE USER REPORTED A QUESTION REGARDING BOX C ON THE FRONT OF THE DRAIN. THE USER STATED THAT THE DEVICE WAS FUNCTIONING AS INTENDED AND REQUESTED CLARIFICATION AS TO WHY THE CHECK MARK WAS NO LONGER PRESENT IN BOX C. AN OFF LABEL USE DISCLAIMER WAS PROVIDED, AND THE INTENDED PURPOSE OF BOX C AND THE SUCTION INDICATOR WAS EXPLAINED TO THE USER. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621450 ↗
• MalfunctionFeb 16, 2026Off-Label Use

  A REPORT WAS RECEIVED THROUGH THE EMERGENCY SUPPORT PROGRAM REGARDING THE ATRIUM EXPRESS MINI CHEST DRAIN. THE PATIENT CONTACTED WITH A QUERY ABOUT HOW TO REMOVE FLUID FROM THE DRAIN, AS IT WAS 96% FULL. THE USER WAS ADVISED TO VISIT THE NEAREST HOSPITAL FOR A DRAIN REPLACEMENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342992 ↗
• MalfunctionJan 24, 2026Off-Label Use

  A REPORT WAS RECEIVED VIA THE EMERGENCY SUPPORT PROGRAM REGARDING THE ATRIUM EXPRESS MINI CHEST DRAIN. THE PATIENT¿S WIFE CONTACTED WITH A QUERY REGARDING DRAINAGE AFTER DISCHARGE FROM THE HOSPITAL AS THE DEVICE DID NOT APPEAR TO BE DRAINING AS EASILY AS IT HAD WHILE IN THE HOSPITAL. SHE DENIED ANY PATIENT SIGNS OR SYMPTOMS OF DECOMPENSATION AND REPORTED NO PATIENT HARM OR INJURY. AN OFF-LABEL DISCLAIMER WAS PROVIDED, AND IT WAS EXPLAINED THAT IN THE HOME SETTING, THE DEVICE FUNCTIONS WITHOUT SUCTION, UTILISING A WATER SEAL TO PROVIDE NEGATIVE PRESSURE. SHE NOTED THAT DRAINAGE APPEARED TO REMAIN IN THE TUBING LONGER THAN IT HAD IN THE HOSPITAL. IT WAS RECOMMENDED TO SEEK EMERGENCY MEDICAL CARE IF THE PATIENT BECAME SYMPTOMATIC OR EXPERIENCED ANY ISSUES WITH THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173605 ↗
• MalfunctionJan 21, 2026Off-Label Use

  A REPORT WAS RECEIVED VIA THE EMERGENCY SUPPORT PROGRAM REGARDING THE ATRIUM EXPRESS MINI CHEST DRAIN. THE PATIENT¿S DAUGHTER REPORTED THAT FOLLOWING THE PATIENT COUGHING, BLOOD FILLED THE DRAINAGE CHAMBER. SHE STATED THE DRAIN HAD COLLECTED APPROXIMATELY 350¿400 ML PRIOR TO THE BLOOD AND LATER REACHED FULL CAPACITY AT 500 ML. SHE WAS UNABLE TO DRAIN THE DEVICE THROUGH THE DRAINAGE PORT AND INQUIRED ABOUT DISCONNECTING THE DRAIN. SHE WAS ADVISED THAT THE DRAIN SHOULD NOT BE DISCONNECTED DUE TO POTENTIAL RISK TO THE PATIENT, AND IT WAS RECOMMENDED THAT THE PATIENT BE TAKEN TO THE ER BECAUSE OF THE BLOOD AND THE DRAIN BEING FULL. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128566 ↗
• MalfunctionNov 27, 2025Off-Label Use; Off-Label Use

  A REPORT WAS RECEIVED FROM A PATIENT'S WIFE REGARDING THE USE OF THE ATRIUM EXPRESS MINI CHEST DRAIN. SHE CONTACTED THE EMERGENCY SUPPORT PROGRAM FOR ASSISTANCE WITH DRAINING THE PORT OF AN EXPRESS MINI 500 DEVICE USING A LUER LOCK SYRINGE. THE DRAIN HAD COLLECTED 420 ML OF FLUID, AND WHILE ATTEMPTING TO EMPTY IT, SHE FOUND THAT HER SYRINGE TIP DID NOT FIT THE PORT AND SHE WANTED TO UNDERSTAND IF THERE WAS ANOTHER WAY TO EMPTY THE DRAIN. IT WAS RECOMMENDED THAT SHE TAKE THE PATIENT BACK TO THE HOSPITAL FOR FURTHER MEDICAL GUIDANCE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663639 ↗
• MalfunctionOct 27, 2025Component Missing; Component Missing

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389484 ↗
• MalfunctionSep 11, 2025Off-Label Use; Off-Label Use

  HOME HEALTH HOSPICE RN CALLED FROM PATIENT'S HOME TO REQUEST ASSISTANCE WITH DRAINING AN EXPRESS MINI 500. THE PATIENT WAS SENT HOME FROM AN UNKNOWN FACILITY WITHOUT INSTRUCTIONS. RN WAS ADVISED OF THE OFF-LABEL USE BUT GIVEN INSTRUCTIONS FOR DRAINING THROUGH THE NEEDLESS SAMPLING ACCESS PORT, AS THE PATIENT WAS ON HOSPICE AND WOULD NOT BE RETURNING TO THE HOSPITAL. RN WAS ADVISED TO VISIT NEAREST EMERGENCY ROOM FOR ONGOING CHEST DRAIN NEEDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034368 ↗
• MalfunctionSep 3, 2025Off-Label Use; Off-Label Use

  REPORT RECEIVED FROM A PATIENT¿S DAUGHTER REGARDING HER MOM ATRIUM EXPRESS MINI CHEST DRAIN DURING USE. SHE CONTACTED THE EMERGENCY SUPPORT PROGRAM REGARDING DIFFICULTY IN DRAINING THE PORT OF AN EXPRESS MINI 500 DEVICE USING A SYRINGE THROUGH THE LUER PORT. THE COLLECTION CHAMBER WAS AT 400 ML, AN INCREASE FROM 150 ML THE PREVIOUS DAY. THE PATIENT WAS ASYMPTOMATIC AND DENIED SHORTNESS OF BREATH. RECOMMENDED THE PATIENT RETURN TO THE HOSPITAL TO HAVE DRAIN EXCHANGE AND CONTACT THE ON-CALL PHYSICIAN FOR FURTHER MEDICAL GUIDANCE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959977 ↗
• MalfunctionJul 22, 2025Off-Label Use; Off-Label Use

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563873 ↗
• MalfunctionJul 20, 2025Off-Label Use; Off-Label Use

  REPORT RECEIVED FROM A PATIENT¿S WIFE REGARDING HER HUSBAND¿S ATRIUM EXPRESS MINI CHEST DRAIN DURING USE. SHE STATED THAT HER HUSBAND WAS RECENTLY DISCHARGED HOME POST-CARDIOTHORACIC SURGERY WITH AN ATRIUM EXPRESS MINI CHEST DRAIN IN PLACE. UPON HER HUSBAND'S DISCHARGE FROM THE HOSPITAL THEY WERE EACH EDUCATED BY THE NURSING STAFF ON HOW TO DRAIN FLUID AS IT COLLECTED IN THE EXPRESS DRAIN. THEY WERE TOLD TO USE A 10CC SYRINGE (PROVIDED BY THE HOSPITAL) TO REMOVE FLUID FROM THE LUER LOCK FLUID SAMPLING PORT. SHE STATED THAT REMOVAL OF FLUID HAD BEEN SUCCESSFUL UP UNTIL CALLING THE 800 LINE. SHE WAS INFORMED DURING THE CALL THAT THE USAGE OF THIS DRAIN AT HOME IS CONSIDERED OFF-LABEL, AND INSTRUCTIONS FOR REMOVING FLUID FROM THE DRAIN COULD NOT BE PROVIDED. IT WAS EXPLAINED TO HER THAT THE REASON SHE WAS UNABLE TO REMOVE FLUID WAS LIKELY DUE TO THE BUILDUP OF FIBRIN CAUSING THE LEUR PORT TO CLOT OFF WHICH WOULD RENDER HER UNABLE TO PULL ANY FLUID FROM IT. SHE REPORTED THAT SHE TRIED INSTILLING WATER INTO THE DRAIN TO TRY TO ¿LOOSEN UP¿ THE SAMPLING PORT. I RECOMMENDED THAT SHE NOT ATTEMPT TO PULL ANY MORE FLUID OR TROUBLESHOOT AT HOME ANY FURTHER. I REVIEWED THAT PER GETINGE'S IFU, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552173 ↗
• MalfunctionJun 27, 2025Off-Label Use; Off-Label Use

  A PATIENT CALLED THE EMERGENCY SUPPORT LINE FROM HOME TO INQUIRE ABOUT THE GENERAL FUNCTION OF A ATRIUM EXPRESS MINI 500 CHEST DRAIN. THE PATIENT HAS INTEREST IN UNDERSTANDING THE CHECK MARK AND THE CLINICAL RELEVANCE OF ITS VISIBILITY. DURING THE DISCUSSION, THE PATIENT SHARED THAT SHE HAD CONTACTED HER CARE TEAM EARLIER WITH QUESTIONS BUT HAD NOT RECEIVED A RESPONSE. THE PATIENT DID NOT DISCLOSE THE HOSPITAL NAME. SHE DID NOT REPORT ANY PROBLEMS WITH THE DRAIN. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344997 ↗
• MalfunctionJun 13, 2025Off-Label Use; Off-Label Use

  REPORT RECEIVED STATED THAT A PATIENT CALLED FROM HER HOME STATED THE MINI EXPRESS 500 CD LUER PORT IS CLOGGED. THE PATIENT HAS BEEN HOME FOR SEVERAL DAYS AFTER DISCHARGE FROM CHRISTIAN NORTHEAST. SHE AND HER HUSBAND HAVE DRAINED FROM THE PORT WITH A SYRINGE 3-5 TIMES. SHE STATES IT IS NOW CLOTTED AND CANNOT BE DRAWN FROM. THE CURRENT FLUID AMOUNT IN THE DRAIN IS ABOUT 300CC. SHE HAD AN AFTER-HOUR NUMBER FOR HER CARE TEAM AT THE HOSPITAL. I ADVISE HER TO CALL THEM TO ADVISE THEM OF THE NEED FOR ANOTHER CHEST DRAIN. I ALSO ADVISED HER TO GO TO THE NEAREST ER IF SHE COULD NOT CONTACT THEM AND RESOLVE THIS TODAY. SHE UNDERSTANDS THAT THE CD IS NOT TO BE USED AT HOME AND THE NEED FOR THIS TO BE RESOLVED BEFORE THE CD FILLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201345 ↗
• MalfunctionMay 25, 2025Off-Label Use; Off-Label Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082827 ↗
• MalfunctionMay 22, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPRESS MINI CHEST DRAIN AT HOME. A CUSTOMER SERVICE CALL WAS RECEIVED FROM SARAH HARING REGARDING AN ISSUE WITH THE EXPRESS MINI 500 DEVICE USED ON HER FATHER-IN-LAW FOR PROLONGED AIR LEAK AND FLUID DRAINAGE. A NEEDLELESS SAMPLING PORT BROKE WHEN A HOME NURSE ATTEMPTED TO REMOVE A SYRINGE AFTER FLUID ACCESS. THE NURSE MAY NOT HAVE PROPERLY UNSCREWED THE LUER LOCK. FLUID AND AIR WERE SEEN LEAKING FROM THE DRAIN. THE PATIENT WAS STABLE AND ADVISED TO VISIT A HOSPITAL FOR EVALUATION. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075582 ↗
• MalfunctionMay 9, 2025Off-Label Use; Off-Label Use

  PATIENT CALLED THE EMERGENCY SUPPORT LINE AFTER BEING DISCHARGED WITH CONCERNS ABOUT USING THE ATRIUM EXPRESS MINI 500 DRAIN AT HOME. PATIENT REPORTED NO HARM, INJURY OR ISSUES AND JUST WANTED TO KNOW WHAT THE LETTERS A, B, AND C ON THE DRAIN MEANT. PATIENT REPORTED NO PROBLEMS WITH THE DRAIN. HE WAS ADVISED TO GO TO THE ER IF HE EXPERIENCED ANY SYMPTOMS LIKE SHORTNESS OF BREATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992271 ↗
• MalfunctionApr 30, 2025Off-Label Use; Off-Label Use

  PATIENT CALLED WITH CONCERNS ABOUT USING THE ATRIUM EXPRESS MINI 500 DRAIN AT HOME. SHE WAS ADVISED TO USE A SYRINGE ON THE LUER PORT TO EMPTY THE CHEST DRAIN, WHICH HAD STOPPED DRAINING PROPERLY. IT WAS EXPLAINED TO HER THAT FIBRIN BUILD-UP MIGHT BE THE CAUSE AND THAT WE CANNOT RECOMMEND MANUAL EMPTYING. ADVISED HER TO VISIT THE ER FOR DRAIN REPLACEMENT AND TO CONTACT HER PHYSICIAN. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934399 ↗
• MalfunctionApr 25, 2025Off-Label Use; Off-Label Use

  REPORT RECEIVED STATED THAT A PATIENT'S WIFE CALLED TO DISCUSS HER HUSBAND¿S CHEST DRAIN. HE HAS AN EXPRESS MINI 500 AND HAS BEEN AT HOME FOR OVER 3 DAYS. SHE STATES HE WAS DISCHARGED FROM (B)(6) HOSPITAL (B)(6), AND THEY DID NOT GIVE HER CARE INSTRUCTIONS. I STATED THAT THE PRODUCT IS NOT APPROVED FOR AT HOME USE AND THAT I COULD ONLY DISCUSS CARE INSTRUCTIONS WITH A CLINICIAN. I ADVISED HER TO CONTACT HER HUSBANDS CARE TEAM FOR FURTHER INSTRUCTIONS. SHE AGREED TO DO SO. SHE DECLINED GIVING ANY FURTHER INFORMATION ABOUT HER HUSBAND OR HER HUSBAND¿S CARE TEAM AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912719 ↗
• MalfunctionApr 22, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPRESS MINI CHEST DRAIN AT HOME. THE PATIENTS WIFE CALLED FOR ASSISTANCE AS SHE WAS UNABLE TO EMPTY THE DRAIN USING THE METHOD SHOWN DURING DISCHARGE. WE REVIEWED THE USE OF THE SYRINGE AND SAMPLING PORT AS SHE HAD BEEN INSTRUCTED BY THE PROVIDER AT DISCHARGE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882481 ↗
• MalfunctionMar 4, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPRESS MINI DRAIN AT HOME. EMERGENCY SUPPORT WAS CALLED DUE TO THE NEEDLESS LUER PORT WAS CLOTTED. BOTH THE PATIENT AND HOME HEALTH NURSE WERE UNABLE TO EMPTY THE COLLECTION CHAMBER VIA THE LUER PORT AS DIRECTED BY HOSPITAL DISCHARGE INSTRUCTIONS. NO PATIENT HARM OR INJURY WAS REPORTED. THE PATIENT WAS ADVISED TO RETURN TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521579 ↗
• MalfunctionFeb 11, 2025Off-Label Use; Off-Label Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353988 ↗
• MalfunctionFeb 6, 2025Off-Label Use; Off-Label Use

  THE PATIENT'S DAUGHTER, REQUESTED ASSISTANCE WITH A CLOGGED LUER PORT ON AN EXPRESS MINI 500 CD. THE PATIENT HAS BEEN USING THE DRAIN AT HOME FOR THE PAST FIVE DAYS. I REVIEWED THE OFF-LABEL USE OF THE PRODUCT IN A HOME SETTING. SHE REPORTED THAT THE CD CURRENTLY CONTAINS APPROXIMATELY 200CC OF FLUID, WHICH SHE HAS BEEN DRAINING ONCE DAILY VIA THE LUER PORT. ADVISED HER TO CONTACT THE PATIENT¿S CARE TEAM OR TAKE THE PATIENT TO THE HOSPITAL ER FOR A CD REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320791 ↗
• MalfunctionJan 15, 2025Off-Label Use; Off-Label Use

  NURSE CALLED REPORTING THAT SHE WAS IN A PATIENT'S HOME AND WAS ATTEMPTING TO EMPTY AN EXPRESS MINI 500 CD USING THE NEEDLELESS LUER PORT AND A SYRINGE. I REVIEWED WITH THE NURSE THE OFF-LABEL AT-HOME USE OF THE PRODUCT AND THAT IT IS RECOMMENDED IN THE IFU THAT IF NEEDLELESS LUER PORT BECOMES CLOGGED, REPLACE WITH A NEW DEVICE. SHE UNDERSTANDS AND THANKS ME FOR THE INFORMATION. NURSE STATED THEY WILL BE GETTING THE PATIENT TO THE ER. THE HOSPITAL CARE TEAM DID NOT SEND THE PATIENT HOME WITH ANOTHER DRAIN. NURSE DOES NOT WISH TO SHARE ANY PATIENT OR PERSONAL INFORMATION BUT DOES COMMUNICATE WHICH HOSPITAL DISCHARGED THE PATIENT TO HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158161 ↗