INTERLINK/CONTROL-A-FLO 2C6891Recalls & reported problems
Baxter International Inc. · Extension Set with CONTROL-A-FLO Regulator, Injection Site, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00085412002422), received between Nov 6, 2020 and Mar 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Prime” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Prime2
- Material Rupture2
- Break1
- Fluid/Blood Leak1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Break; Fluid/Blood Leak
IT WAS REPORTED THAT FOUR (4) INTERLINK SYSTEM EXTENSION SETS HAD ISSUES DURING PATIENT USE. THE REGULATOR WAS OBSERVED TO BE LEAKING ON THREE INSTANCES. THE LINES WERE OBSERVED TO BE FILLED WITH BLOOD ON TWO OCCASIONS. ADDITIONALLY, WHEN AN IV FLUSH WAS ADMINISTERED AT THE INJECTION SITE, THE REGULATOR BROKE ON TWO INSTANCES. 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 24717629 ↗MalfunctionJan 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT AN INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO REGULATOR RUPTURED WHICH RESULTED IN A FLUID LEAK. THIS EVENT OCCURRED DURING PATIENT THERAPY WITH UNSPECIFIED MEDICATION. 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 18521497 ↗MalfunctionJan 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT THEAN INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO REGULATOR RUPTURED. 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 18504869 ↗MalfunctionNov 17, 2020No Flow; No Flow
IT WAS REPORTED THE ¿FLOW METER¿ OF AN UNKNOWN QUANTITY OF INTERLINK SYSTEM EXTENSION SETS WOULD NOT FLOW AND HAD TO BE DISCONNECTED. THE NURSES STATED THAT ¿THE FLOW METER WOULD FLOW ON OPEN BUT WOULD NOT DRIP IF FLOW RATE WAS TURNED UP¿. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSIONS. 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 10853085 ↗MalfunctionNov 17, 2020Failure to Prime; Failure to Prime
IT WAS REPORTED THAT THE ¿FLOW METER¿ OF AN UNKNOWN QUANTITY OF INTERLINK SYSTEM EXTENSION SETS WOULD NOT PRIME AND HAD TO BE DISCONNECTED. THE NURSES STATED THAT ¿THE FLOW METER WOULD FLOW ON OPEN BUT WOULD NOT DRIP IF FLOW RATE WAS TURNED UP¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10853084 ↗MalfunctionNov 6, 2020Failure to Prime; Failure to Prime
IT WAS REPORTED THAT THE ¿FLOW METER¿ OF AN UNSPECIFIED QUANTITY, WITHIN THE TEN (10) REPORTED UNITS, OF INTERLINK SYSTEM EXTENSION SETS WITH CONTROL-A-FLO REGULATORS WOULD NOT PRIME AND HAD TO BE DISCONNECTED. THE NURSES STATED THAT ¿THE FLOW METER WOULD FLOW ON OPEN BUT WOULD NOT DRIP IF FLOW RATE WAS TURNED UP¿. THIS ISSUE WAS IDENTIFIED DURING THE PRIMING STEP. 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 10805003 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page