INTERLINK/CONTINU-FLORecalls & reported problems across all models
Baxter Healthcare Corporation · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of INTERLINK/CONTINU-FLO by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2018 and Feb 26, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Disconnection” (9 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. 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
Most reported INTERLINK/CONTINU-FLO problems
Device problems
- Disconnection9
- Fluid/Blood Leak9
- Loose or Intermittent Connection4
- Device Contamination with Chemical or Other Material2
- Illegible Information2
- No Flow2
- Detachment of Device or Device Component1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Patient Involvement8
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
INTERLINK/CONTINU-FLO models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTERLINK/CONTINU-FLO 2C6571Set, administration, intravascular8 reports
- INTERLINK/CONTINU-FLO 3C0062Stopcock, i.V. Set6 reports
- INTERLINK/CONTINU-FLO 2C6519Set, administration, intravascular3 reports
- INTERLINK/CONTINU-FLO 2C6537Set, administration, intravascular3 reports
- INTERLINK/CONTINU-FLO 2H6519Set, administration, intravascular2 reports
Recent INTERLINK/CONTINU-FLO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A CONTINUE-FLO SOLUTION SET HAD A FOREIGN OBJECT INSIDE THE TUBING. THIS WAS NOTICED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469320 ↗MalfunctionJan 3, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) NON-DEHP CONTINU-FLO SOLUTION SETS WERE NOT CONNECTING APPROPRIATELY WITH A CLOSED SYSTEM TRANSFER DEVICE END PIECE AND AN ADD-ON FILTER. THE LUER END WAS NOT FULLY LOCKING ON TO ANY ADD ON PIECES AND RESULTED IN THE SLOW LEAK DURING TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072214 ↗MalfunctionOct 14, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED. THE TUBING WAS NOT STAYING CONNECTED TO THE HUB WHICH CAUSED FLUID FROM THE IV (INTRAVENOUS) BAG TO LEAK. THIS OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439744 ↗MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING OF A CONTINU-FLO SOLUTION SET SNAPPED AT THE JUNCTION OF THE INJECTION PORT THAT WAS CLOSEST TO THE PATIENT. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17925139 ↗MalfunctionFeb 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAK FROM THE JOINT OF THE TUBING TO THE MALE LUER OF A CONTINU-FLO SOLUTION SET. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH REMICADE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16404054 ↗MalfunctionFeb 10, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS WERE LEAKING WITH REMICADE. THE LEAK WAS COMING FROM A PIN HOLE ON THE TUBING NEAR THE SCREW END OF THE CATHETER. THIS WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16355161 ↗MalfunctionNov 30, 2021Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection; Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYTEM CONTINU-FLO SOLUTION SET LARGE BORE 4-WAY STOPCOCK EXTENSION SETS WERE LOOSE AND CAME APART AT THE STOPCOCK WHICH RESULTS IN LEAKS. THIS WAS IDENTIFIED IN THE OUT PATIENT SURGERY DEPARTMENT WHILE HOOKING UP TO IV (INTRAVENOUS) LINES. THIS WAS FURTHER DESCRIBED AS THEY ARE NOT STAYING TOGETHER ¿EVEN WHEN THEY TIGHTEN THE CONNECTION WITH AS MUCH FORCE AS THEY COULD, IT DID NOT STAY¿. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12897496 ↗MalfunctionNov 19, 2021Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection; Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM CONTINU-FLO SOLUTION SET LARGE BORE 4-WAY STOPCOCK EXTENSION SETS CAME APART AT THE STOPCOCK. ONE (1) SET FELL APART WHILE HOOKING UP THE PATIENT WHICH ALSO RESULTED IN A FLUID AND BLOOD LEAK. THE OTHER UNSPECIFIED QUANTITY OF SETS WERE ALL LOOSE AT THE STOPCOCK WHILE CHECKING THEM PRIOR TO PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849046 ↗MalfunctionNov 19, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE CONNECTION TO THE STOPCOCK OF THE UNSPECIFIED QUANTITY OF INTERLINK SYTEM CONTINU-FLO SOLUTION SETS WOULD NOT STAY. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12844075 ↗MalfunctionNov 19, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTERLINK SYTEM CONTINU-FLO SOLUTION SET CAME APART AT THE STOPCOCK WHICH RESULTED IN AN INTRAVENOUS FLUID LEAK. THIS WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12844012 ↗MalfunctionNov 16, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT THE SHIPPING LABEL OF THE UNKNOWN QUANTITY OF CONTINU-FLO SOLUTION SETS WAS PLACED OVER THE BARCODE AND PRODUCT DETAILS. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10845952 ↗MalfunctionNov 16, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT THE SHIPPING LABEL OF THE UNKNOWN QUANTITY OF CONTINU-FLO SOLUTION SETS WAS PLACED OVER THE BARCODE AND PRODUCT DETAILS. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10845488 ↗MalfunctionSep 8, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE IV TUBING OF 2 NON-DEHP CONTINU-FLO SOLUTION SETS POPPED OFF AT THE SCREW-ON COLLAR. THE EVENT WAS FURTHER REPORTED AS "THE COLLAR DOES NOT ENGAGE, JUST KEEPS SPINNING AROUND AND NOT TIGHTENING". THE EVENT OCCURRED PRIOR TO ATTACHING TO THE PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10505878 ↗MalfunctionJul 1, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING OF CONTINU-FLO SOLUTION SET FELL APART AND CAME OUT OF THE CANNULA WHEN ATTEMPTING TO REMOVE THE TIP PROTECTOR. THIS RESULTED IN A WASTE OF IMMUNOGLOBULIN IN THE TUBING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10218694 ↗MalfunctionFeb 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE LUER OF THREE (3) CONTINU-FLO SOLUTION SETS WOULD NOT "MEET" THE HUB OF THE INTRAVENOUS (IV) CATHETER CORRECTLY DURING USE. THIS ISSUE RESULTED IN A LEAK OF DRUG MEDICATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9734259 ↗
Other Baxter Healthcare Corporation products
- EXACTAMIX28 models · 6,739 reports · 13 recalls
- MiniCap3 models · 3,423 reports · 7 recalls
- Novum IQ3 models · 1,540 reports · 7 recalls
- CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
- CLEARLINK19 models · 710 reports · 4 recalls
- CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
- CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
- REPEATER6 models · 189 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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