EXPRESSRecalls & reported problems across all models

We found 3 models of EXPRESS by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 142 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2016 and Aug 12, 2026 — classified as 14 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (83 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. 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

EXPRESS 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. Dec 13, 2023Class IOpen, Classified

   Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

   Z-0710-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. Dec 13, 2023Class IOpen, Classified

   Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

   Z-0709-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

3. Sep 18, 2023Class IIOpen, Classified

   Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

   Z-0318-2024 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗

4. Mar 1, 2023Class IIOpen, 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 · Recall details · FDA record ↗

Most reported EXPRESS problems

EXPRESS models

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

• EXPRESS 16400

  BOTTLE, COLLECTION, VACUUM
  1 recall110 reports
• EXPRESS 4000-100N

  Bottle, Collection, Vacuum
  2 recalls30 reports
• EXPRESS 4050-100N

  APPARATUS, AUTOTRANSFUSION
  2 recalls2 reports

Recent EXPRESS adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Atrium Medical Corporation products

• ADVANTA SLIDER GDS51 models · 76 reports · 51 recalls
• FLIXENE SLIDER GDS17 models · 52 reports · 17 recalls
• PROLITE23 models · 515 reports
• OASIS6 models · 270 reports · 4 recalls
• PROLOOP12 models · 355 reports
• OCEAN10 models · 111 reports · 4 recalls
• iCAST29 models · 197 reports
• C-QUR V-PATCH3 models · 165 reports