INTERLINK 2C6671Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412003993), received between Jun 19, 2018 and Jan 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K153158); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM EXTENSION SET LEAKED FLUID DOWN AROUND THE TUBING ONTO THE FLOOR. THE ISSUE WAS OBSERVED DURING PRIMING, AFTER SPIKING A NORMAL SALINE 250 ML BAG OF REMICADE. IT WAS FURTHER SPECIFIED THAT THE "SPIKE PIERCED THROUGH PLASTIC AT ENTRY POINT AT AN ANGLE CAUSING THE SIDE WALL OF THE ENTRY PORT TO RUPTURE". NEW DOSE OF REMICADE WAS DISPENSED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217992 ↗
• MalfunctionNov 13, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM EXTENSION SET BROKE RESULTING IN A BLOOD LEAK; A "POP" WAS HEARD AT THE TIME OF THE EVENT. THIS WAS OBSERVED DURING PATIENT INFUSION. THE SET WAS DISCONNECTED TO RESOLVE THE 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 20674635 ↗
• MalfunctionMay 14, 2024Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  IT WAS REPORTED THAT AN INTERLINK SYSTEM EXTENSION SET HAD DARK BROWN, RUST-LOOKING SEDIMENTS SEEN IN THE FILTER TUBING. THIS WAS OBSERVED AFTER COMPLETION OF INFUSION WITH AMIODARONE. 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 19309407 ↗
• MalfunctionMay 13, 2024Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  IT WAS REPORTED THAT AN INTERLINK SYSTEM EXTENSION SET HAD DARK BROWN, RUST-LOOKING SEDIMENTS SEEN IN THE FILTER TUBING. THIS WAS OBSERVED AFTER COMPLETION OF INFUSION WITH AMIODARONE. 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 19298902 ↗
• MalfunctionMar 23, 2023Backflow; Backflow

  IT WAS REPORTED THAT BLOOD WAS BACKING UP THE TUBING OF THREE (3) INTERLINK SYSTEM EXTENSION SETS. THE FILTER ON THE SETS DID NOT FILL WITH FLUID. 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 16599867 ↗
• MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM EXTENSION SET LEAKED FROM UNSPECIFIED LOCATION. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174897 ↗
• MalfunctionMar 18, 2019Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THERE WAS BACKFLOW IN AN UNSPECIFIED NUMBER OF INTERLINK SOLUTION ADMINISTRATION SETS WHILE IN USE ON A PATIENT. IT WAS STATED THAT THE NURSE PRIMED THE IV (INTRAVENOUS) TUBING AND FILTER AND ATTACHED IT TO THE PATIENT¿S CENTRAL LINE. THE EXTENSION SET WAS POSITIONED NEAR THE PATIENT¿S ARM AT OR BELOW THE LEVEL OF THE PATIENT¿S HEART. SUBSEQUENTLY BLOOD BACKED UP INTO THE FILTER. WHEN THE NURSE PICKED UP THE SET, THE BLOOD AND FLUID DRAINED BACK TO THE PATIENT, BUT AFTER THAT THERE WAS NO FLUID (JUST AIR) IN THE LINE FROM THE FILTER TO THE PATIENT; FURTHER DESCRIBED AS ¿DRAINED DRY¿ FROM THE FILTER TO THE PATIENT. THE NURSE EXCHANGED THE EXTENSION SET SEVERAL TIMES (EXACT NUMBER UNKNOWN) AND EACH TIME THE SAME THING HAPPENED. EVENTUALLY THE ADMINISTRATION SET DID WORK AFTER TRYING SEVERAL NEW SETS. 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 8429766 ↗
• MalfunctionMar 18, 2019Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THERE WAS BACKFLOW IN AN UNSPECIFIED NUMBER OF INTERLINK SOLUTION ADMINISTRATION SETS WHILE IN USE ON A PATIENT. IT WAS STATED THAT THE NURSE PRIMED THE IV (INTRAVENOUS) TUBING AND FILTER AND ATTACHED IT TO THE PATIENT¿S CENTRAL LINE. THE EXTENSION SET WAS POSITIONED NEAR THE PATIENT¿S ARM AT OR BELOW THE LEVEL OF THE PATIENT¿S HEART. SUBSEQUENTLY BLOOD BACKED UP INTO THE FILTER. WHEN THE NURSE PICKED UP THE SET, THE BLOOD AND FLUID DRAINED BACK TO THE PATIENT, BUT AFTER THAT THERE WAS NO FLUID (JUST AIR) IN THE LINE FROM THE FILTER TO THE PATIENT; FURTHER DESCRIBED AS ¿DRAINED DRY¿ FROM THE FILTER TO THE PATIENT. THE NURSE EXCHANGED THE EXTENSION SET SEVERAL TIMES (EXACT NUMBER UNKNOWN) AND EACH TIME THE SAME THING HAPPENED. EVENTUALLY THE ADMINISTRATION SET DID WORK AFTER TRYING SEVERAL NEW SETS. 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 8429761 ↗
• MalfunctionMar 18, 2019Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THERE WAS BACKFLOW IN AN UNSPECIFIED NUMBER OF INTERLINK SOLUTION ADMINISTRATION SETS WHILE IN USE ON A PATIENT. IT WAS STATED THAT THE NURSE PRIMED THE IV (INTRAVENOUS) TUBING AND FILTER AND ATTACHED IT TO THE PATIENT¿S CENTRAL LINE. THE EXTENSION SET WAS POSITIONED NEAR THE PATIENT¿S ARM AT OR BELOW THE LEVEL OF THE PATIENT¿S HEART. SUBSEQUENTLY BLOOD BACKED UP INTO THE FILTER. WHEN THE NURSE PICKED UP THE SET, THE BLOOD AND FLUID DRAINED BACK TO THE PATIENT, BUT AFTER THAT THERE WAS NO FLUID (JUST AIR) IN THE LINE FROM THE FILTER TO THE PATIENT; FURTHER DESCRIBED AS ¿DRAINED DRY¿ FROM THE FILTER TO THE PATIENT. THE NURSE EXCHANGED THE EXTENSION SET SEVERAL TIMES (EXACT NUMBER UNKNOWN) AND EACH TIME THE SAME THING HAPPENED. EVENTUALLY THE ADMINISTRATION SET DID WORK AFTER TRYING SEVERAL NEW SETS. 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 8429720 ↗
• MalfunctionJun 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER OF AN INTERLINK SOLUTION ADMINISTRATION SET FILLED WITH AIR AND LEAKED TOTAL PARENTERAL NUTRITION (TPN) FROM THE END OF THE TUBING. THIS EVENT OCCURRED WHILE PRIMING THE DEVICE. IT WAS FURTHER REPORTED THAT ONCE THE DEVICE LEAKED IT WAS THEN REPRIMED AND THE FILTER WAS ADJUSTED. THE DEVICE LEAKED TPN SOLUTION AGAIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7614277 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.

• Z-0196-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
• Z-0195-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8