AltitudeRecalls & reported problems across all models
Cardinal Health 200, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Altitude model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of Altitude by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between May 12, 2017 and Jun 4, 2024 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
Altitude 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.
- Dec 26, 2025Open, Classified
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Z-1203-2026 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported Altitude problems
Device problems
- Detachment of Device or Device Component6
- Suction Problem3
- Leak/Splash2
- Air Leak1
- Decrease in Suction1
- Kinked1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Information1
Altitude models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Altitude 8888571370APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Altitude 8888571370Apparatus, Suction, Operating-Room, Wall Vacuum Powered14 reports
Recent Altitude adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19464208 ↗MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19464207 ↗MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19464191 ↗MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CLOSED CHEST TUBE DRAINAGE SYSTEM (AQUA-SEAL) SHOWED DISCONNECTION WITHOUT TRACTION. THE CUSTOMER STATED THAT THE COLLECTION BOTTLE EXTENSION (AQUA-SEAL) THAT CONNECTS TO THE CHEST DRAIN IS MADE OF PVC MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19463961 ↗MalfunctionMar 26, 2024Suction Problem; Suction Problem
THE CUSTOMER REPORTED THAT THE PATIENT ARRIVED TO THE CICU FOLLOWING CARDIAC SURGERY. WHEN CARDIAC DRAINS WERE ATTACHED TO THE APPROPRIATE SUCTION, IT DID NOT WORK EFFECTIVELY. THE GREEN SUCTION / PATIENT VACUUM INDICATOR DID NOT APPEAR AS IT SHOULD ON THE ALTITUDE DRAIN. WALL SUCTION WAS CHECKED AND IT WAS WORKING ADEQUATELY THEREFORE THE ISSUE WAS WITH THE ALTITUDE CDU DRAINAGE BOTTLE. THERE HAS BEEN 4 SIMILAR INCIDENTS (EXACT NUMBER UNKNOWN) IN THE RECENT PAST REGARDING THE SAME ISSUE. PER ADDITIONAL INFORMATION RECEIVED, THE BEDSIDE NURSE ESCALATED THE ISSUE WITH NOT BEING ABLE TO SEE THERE WAS SUCTION BEING APPLIED. AFTER INVESTIGATING AND CHECKING THE WALL SUCTION WAS WORKING, THE DECISION WAS MADE TO CHANGE THE DRAINAGE BOTTLE TO ENSURE PATIENT SAFETY. THIS IS AN UNNECESSARY INTERVENTION (AS THE DRAINS SHOULD BE WORKING APPROPRIATELY WITH ANY ADDED SUCTION BEING INDICATED). THERE WAS NO HARM TO THE PATIENT, HOWEVER IT IS OF GREAT IMPORTANCE THAT THE DRAINS BE ON SUCTION DUE TO THE NATURE OF THE SURGERY, THE CHANGING OF THE DRAINAGE BOTTLE INCREASES THE RISK OF INFECTION TO THE PATIENT DESPITE THE PROCEDURE BEING DONE USING ANTT/ IN A STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18981914 ↗InjurySep 6, 2022Suction Problem; Suction Problem
THE CUSTOMER REPORTED THAT THE PATIENT WAS WITH A CHEST TUBE SINCE (B)(6) 2022 DUE TO THE PRESENCE OF HEMOTHORAX. THEY WERE ADMITTED TO THE INTERMEDIATE CARE UNIT ON (B)(6) 2022 AND ON (B)(6) 2022 DRAINAGE WAS OBSERVED IN THE WATER SEAL CHAMBER AND REST OF THE DRAINAGE IN ALL THE COLLECTING CHAMBERS WITHOUT THE FIRST ONE BEING FULL. IN ROUNDS, THE DOCTOR REPORTS THE FINDING AND THAT THE MEDICAL DEVICE HAS NOT FALLEN, SO A CHEST TOMOGRAPHY IS PERFORMED AND EVIDENCE OF COAGULATED HEMOTHORAX REQUIRING SURGICAL INTERVENTION THE NEXT DAY TO PERFORM DRAINAGE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15365364 ↗MalfunctionAug 25, 2020Decrease in Suction; Decrease in Suction
THE CUSTOMER REPORTED THEY HAVE NOTICED THAT THE ALTITUDE CHEST DRAINAGE SYSTEM DOES NOT MAINTAIN SUCTION AND THE TEAMS REPORT AN AIR LEAK SOUND. THE PATIENT HAD TO RETURN TO THE RECOVERY ROOM TO CHANGE THE DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10448194 ↗MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTS A DISCONNECTION OCCURRED WHERE THE TROCAR CATHETER CONNECTS TO THE TUBING/CONNECTOR PIECE OF THE CHEST DRAINAGE UNIT. THE CONNECTION IS INITIALLY TIGHT, BUT BECAME LOOSE AND DISCONNECTED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8684290 ↗MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTS A DISCONNECTION OCCURRED WHERE THE TROCAR CATHETER CONNECTS TO THE TUBING/CONNECTOR PIECE OF THE CHEST DRAINAGE UNIT. THE CONNECTION IS INITIALLY TIGHT, BUT BECAME LOOSE AND DISCONNECTED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8682924 ↗MalfunctionJun 27, 2018Leak/Splash; Leak/Splash
CUSTOMER REPORTS: ON ARRIVAL TO THE DCCM POST-OP CARDIAC BYPASS SURGERY, THE ALTITUDE CHEST DRAIN WAS PLACED ON -20CMH20. THE DRAIN COMMENCED BUBBLING CONSTANTLY THROUGHOUT INSPIRATION AND EXPIRATION ON A VENTILATED PATIENT. SUCTION WAS REMOVED AND THE DRAIN STOPPED BUBBLING. WHEN THE SUCTION WAS REAPPLIED, THE DRAIN RESUMED BUBBLING. THE DRAINAGE TUBING WAS THEN OCCLUDED, AND THE BUBBLING CONTINUED. WHEN THE SUCTION WAS REDUCED TO -10CMH20, THE BUBBLING CONTINUED. THE CLINICIAN CHANGED THE ALTITUDE DRAIN TO ANOTHER ALTITUDE DRAIN IN STOCK, RESUMED -20CMH20 AND THE BUBBLING CEASED. SWINGING (OSCILLATION) AND DRAINAGE WERE UNAFFECTED. PER FOLLOW UP INFORMATION RECEIVED, THE CUSTOMER FURTHER STATED THAT THERE WAS A LEAKAGE IN THE WATER SEAL CHAMBER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7643104 ↗MalfunctionDec 22, 2017Air Leak; Air Leak
MalfunctionOct 17, 2017Kinked; Kinked
ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING USE, THE DEVICE'S DRAINAGE HAD LEAKAGE AND NO PRESSURE WHEN TUBING WAS KINKED. THE PATIENT WAS ALIVE WITH NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6955430 ↗MalfunctionAug 4, 2017Suction Problem; Suction Problem
THE CUSTOMER REPORTS LEAK AT THE LEVEL OF "SATCHEL". THERE ARE SOME ABNORMAL BUBBLES. WHILE THE PATIENT HAD A PULMONARY LEAK PROBLEM. THE "SATCHEL" DOESN'T WORK, THEREFORE NO SUCTION FOR THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6768361 ↗MalfunctionMay 12, 2017Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED SIGNIFICANT LEAKAGE OF PLEURAL FLUID AT THE BLUE FITTING IN THE WATER SEAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6562958 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 reports · 11 recalls
- CONVERTORS38 models · 40 reports · 11 recalls
- Argyle33 models · 58 reports · 7 recalls
- Salem Sump31 models · 40 reports · 7 recalls
- Dover45 models · 241 reports · 2 recalls
- Kendall31 models · 51 reports · 3 recalls
- Kangaroo35 models · 130 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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