INTERLINK 1C8740Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412082028), received between Jan 25, 2019 and May 14, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LUER LOCK ADAPTER OF AN INTERLINK NON-DEHP MINIVOLUME EXTENSION SET SEPARATED FROM THE TUBING. IT WAS OBSERVED THAT THE DISTAL END OF THE ¿CARDIAC FILTER TUBING¿ REMAINED ATTACHED TO THE PATIENT¿S CVD RED LUMEN WHILE THE REMAINDER OF THE TUBING HAD BROKEN OFF. 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 25178676 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT A NON-DEHP MINIVOLUME EXTENSION SET LEAKED FROM THE "RUBBER PORT ON THE MED LINE FILTER" (INTERLINK COMPONENT) DURING A MAGNESIUM INFUSION; THE RUBBER STOPPER WAS "HALF OUT". THE PATIENT STILL RECEIVED A MAJORITY OF THE 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 25033825 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RUBBER HUB AT THE Y-CONNECTOR OF AN INTERLINK NON-DEHP MINIVOLUME EXTENSION SET WAS DISPLACED WHICH RESULTED IN A FLUID LEAK. THIS ISSUE WAS OBSERVED WHILE PRIMING THE SET PRIOR TO PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299174 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE ACCESS POINT OF A MICRO-VOLUME EXTENSION SET HAD A DEFECTIVE RUBBER PORTION AND LEAKED. THIS WAS OBSERVED DURING USE. A PEDI PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS USED. 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 23057665 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM MINIVOLUME EXTENSION SET LEAKED FROM THE AIR FILTER TUBING. THIS WAS OBSERVED PRIOR TO USE FOR A METHYLENE 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 23009497 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK NON-DEHP MINIVOLUME EXTENSION SET WAS LEAKING FROM THE FILTER. THE LEAK FROM THE FILTER WAS OBSERVED WHILE FLUSHING THE SET WITH NORMAL SALINE AFTER THE PATIENT HAD RECEIVED AN ELECTROLYTE REPLETION. 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 22699038 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM NON-DEHP MINIVOLUME EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION AFTER PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385133 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP MINIVOLUME EXTENSION SET LEAKED AFTER PRIMING. 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 20384751 ↗
• MalfunctionFeb 20, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM NON-DEHP MINIVOLUME EXTENSION SETS WERE LEAKING FROM A HOLE IN THE FILTER. THE LEAKS WERE OBSERVED A FEW HOURS LATER AFTER THE PATIENT WAS CONNECTED FOR THERAPY. THIS ISSUE WAS NOT OBSERVED DURING PRIMING. 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 9734936 ↗
• MalfunctionJan 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT AN INTERLINK MICRO-VOLUME EXTENSION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. IT WAS NOT SPECIFIED IF A PATIENT WAS INVOLVED IN THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 8280044 ↗