CLEARLINK/CONTINU-FLO 2C8931Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00085412071725), received between Jan 12, 2018 and Nov 11, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Disconnection” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR ENTERING THE LINE OF CLEARLINK CONTINU-FLO SOLUTION SET THROUGH THE MANIFOLD LOCATED DIRECTLY ABOVE THE STOP COCK. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED DURING THIS EVENT. 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 23523414 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AT THE Y-SITE. THE ISSUE WAS FURTHER DESCRIBED AS, THIS OCCURRED WHILE ADMINISTERING MEDICATION DURING INTUBATION THROUGH ONE OF THE PORTS CLOSEST TO THE PATIENT, RESULTING IN THE MEDICATION LEAKING FROM THE PORT DIRECTLY BELOW IT INSTEAD OF BEING DELIVERED TO THE PATIENT. 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 23408300 ↗
• MalfunctionAug 4, 2023Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT BOTH SIDES OF THE MANIFOLD OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS LOOSELY CONNECTED. THIS WAS FOUND UPON REMOVING THE TUBING FROM THE PACKAGE. THE CONNECTIONS WERE TIGHTENED AND CHECKED PRIOR TO STARTING THE INFUSION. SUBSEQUENTLY, THE CONNECTIONS WERE FOUND LOOSE AGAIN AND THE ANESTHESIOLOGIST FOUND THE TUBING DISCONNECTED FROM THE MANIFOLD AND A BLOOD/MEDICATION PUDDLE ON THE FLOOR BECAUSE THE MANIFOLD CONNECTIONS HAD DISCONNECTED. THE PATIENT DID NOT MOVE FROM THE PRE-OP CHAIR WHEN THIS WAS FOUND. 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 17466498 ↗
• MalfunctionJul 27, 2023Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT BOTH SIDES OF THE MANIFOLD OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS LOOSELY CONNECTED. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THE CONNECTIONS WERE HAND TIGHTENED TWICE PRIOR TO THE TUBING BECOMING DISCONNECTED¿. 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 17406919 ↗
• MalfunctionJul 3, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THERE WAS NO INNER VALVE ON ONE OF THE PORTS OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET. THE MANIFOLD CONNECTIONS CAME LOOSE EVENT AFTER TIGHTENING.THE ISSUE OCCURRED AFTER PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249416 ↗
• MalfunctionMar 15, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS EXPERIENCED DISCONNECTIONS FROM THE MANIFOLD PORT. THE CONNECTION ISSUES OCCURRED 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 13769157 ↗
• MalfunctionMar 9, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET EXPERIENCED A DISCONNECTION FROM THE MANIFOLD PORT WHICH RESULTED IN A BLOOD LEAK. THE CONNECTION ISSUE OCCURRED DURING PATIENT THERAPY. 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 13711404 ↗
• MalfunctionMar 9, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS EXPERIENCED DISCONNECTIONS FROM THE MANIFOLD PORT. THE CONNECTION ISSUES OCCURRED 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 13711129 ↗
• MalfunctionDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED 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 Consequences Or Impact To Patient

  MAUDE report 11091056 ↗
• MalfunctionDec 9, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED FIFTEEN (15) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WOULD NOT CONNECT. THE DEFECT WAS FURTHER DESCRIBED AS "THE END WOULD NOT SCREW TOGETHER". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10976814 ↗
• MalfunctionNov 13, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT THE MANIFOLD OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS CRACKED, BENT AND NOT WORKING. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9318326 ↗
• MalfunctionNov 11, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT "THE MANIFOLD ON EITHER END" OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS "CRACKED, BENT AND NOT WORKING". THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9305882 ↗
• MalfunctionApr 29, 2019Failure to Prime; Failure to Prime

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WOULD NOT PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8560704 ↗
• MalfunctionApr 24, 2019Connection Problem; Connection Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK CONTINU-FLO SOLUTION SETS EXPERIENCED CONNECTION ISSUES. THE CLEAR PLASTIC PIECE ON THE END OF THE TUBING WHICH ATTACHES TO THE PATIENT WOULD NOT TWIST TO LOCK ONTO THE LUER LOCK. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. IT WAS NOT SPECIFIED WHETHER THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8547299 ↗
• MalfunctionJan 12, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET DISCONNECTED DURING INFUSION, LEADING TO A BLOOD LEAK. THE AMOUNT OF PATIENT BLOOD LOSS WAS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187599 ↗
• MalfunctionJan 12, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET SEPARATED FROM THE ADMINISTRATION PORT. THIS OCCURRED DURING INFUSION. THE REPORTER STATED THAT THE PATIENT ¿BLED OUT¿ (EVENT NOT FURTHER CLARIFIED). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187587 ↗
• MalfunctionJan 12, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET SEPARATED FROM THE ADMINISTRATION PORT. THIS OCCURRED DURING 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 7187549 ↗
• MalfunctionJan 12, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET SEPARATED FROM THE ADMINISTRATION PORT. THIS OCCURRED DURING 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 7187522 ↗
• MalfunctionJan 12, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET SEPARATED FROM THE ADMINISTRATION PORT. THIS OCCURRED DURING 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 7187520 ↗