CLEARLINK/CONTROL-A-FLO 2C8891Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00085412046396), received between Oct 22, 2018 and Aug 26, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461950 ↗
• MalfunctionNov 26, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH BETWEEN SIX (6) AND TEN (10) CLEARLINK EXTENSION SETS WITH CONTROL-A-FLO REGULATOR. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF THESE EVENTS. 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 23657185 ↗
• MalfunctionAug 26, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET BURST WHEN COMPUTED TOMOGRAPHY (CT) CONTRAST WAS INJECTED INTO THE PORT DURING PATIENT INFUSION. THE SET WAS INFUSING FLUID AT A FIXED (UNSPECIFIED) RATE VIA GRAVITY. WHEN CONNECTING THE INJECTOR TO THE PORT, THE CONNECTOR INJECTED THE DYE INTO THE LINE AT A PRESSURIZED RATE. THIS DISRUPTED THE GRAVITY FLOW THAT WAS ALREADY DRIPPING CAUSING THE INJECTOR TO COME OFF THE PORT OF THE TUBING CONNECTED TO IT. THE SET WAS DISCONNECTED AND THE PATIENT WAS ABLE TO RECEIVE THE DYE WITHOUT ISSUE. 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 22898626 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT A CONTROL-A-FLO REGULATOR (DIAL) OF TWO (2) CLEARLINK SYSTEM EXTENSION SETS BROKE IN HALF. THIS OCCURRED WHEN THE NURSE FLUSHED THE LINE. 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 20158501 ↗
• MalfunctionOct 20, 2021Filling Problem; Filling Problem

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM EXTENSION SETS OVER INFUSED. IT WAS FURTHER SPECIFIED THAT UNSPECIFIED SOLUTIONS WERE BEING DELIVERED TO PATIENTS AT A HIGHER RATE THAN EXPECTED. 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 12669712 ↗
• MalfunctionSep 10, 2021Backflow; Backflow

  IT WAS REPORTED THAT THERE WAS BACKFLOW WHILE USING A CLEARLINK SYSTEM EXTENSION SET. IT WAS FURTHER REPORTED THAT THE NURSE HUNG THE SECONDARY LINE TO THE Y-SITE ABOVE THE CLEARLINK SYSTEM EXTENSION SET AND THE "K-RIDER" BACK PRIMED INTO THE PRIMARY FLUIDS. THIS WAS IDENTIFIED DURING 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 12452992 ↗
• MalfunctionJul 9, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FLOW REGULATOR OF A CLEARLINK SYSTEM EXTENSION SET WAS CRACKED WHICH RESULTED IN A LEAK. THE LEAK OF INTRAVENOUS (IV) FLUID WAS DISCOVERED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10253693 ↗
• MalfunctionMar 25, 2020Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET BROKE APART DURING FLUSHING OF UNSPECIFIED FLUID. 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 9880216 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO REGULATOR BROKE. IT WAS FURTHER REPORTED THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, THE "CONTROL-A-FLO REGULATOR ON IV EXTENSION TUBING BROKE PREVENTING PATIENT FROM RECEIVING SEDATIVE MEDICATIONS, HEPARIN, AND IV FLUIDS". THE PATIENT ALSO "HAS SOME SMALL VOLUME BLOOD LOSS". THE DEVICE WAS "REMOVED AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES". THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444284 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT THE CONNECTOR OF A CLEARLINK EXTENSION SET WAS "BROKE OFF". THIS WAS IDENTIFIED WHEN THE NURSE "OPENED PRODUCT" 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 Patient Involvement

  MAUDE report 9287946 ↗
• MalfunctionJul 12, 2019Filling Problem; Filling Problem

  IT WAS REPORTED THAT THERE WAS AN UNDERINFUSION OF MEDICATION TO A PATIENT WHILE USING A CLEARLINK SYSTEM EXTENSION SET. THE MEDICATION DELIVERY WAS INTENDED TO BE COMPLETED IN THREE HOURS; HOWEVER, THE INFUSION WAS NOT COMPLETED UNTIL FOUR HOURS AFTER THE START OF THERAPY. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784688 ↗
• MalfunctionOct 22, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A CLEARLINK I.V. ADMINISTRATION SET CAME APART AT AN UNSPECIFIED DEVICE LOCATION. THE INCIDENT OCCURRED WHILE IN USE ON A PATIENT. 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 7991677 ↗