INTERLINK 2C1103Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412000503), received between Sep 11, 2018 and Aug 6, 2026 — classified as 1 injury, 6 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K952074); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161152 ↗
• MalfunctionJun 5, 2025Break; Fluid/Blood Leak; No Flow; Break; Fluid/Blood Leak; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH AN INTERLINK NON-DEHP EXTENSION SET. WHILE FLUSHING THE SET, IT WAS OBSERVED THAT THERE WAS NO FLUID FLOW WHICH CREATED PRESSURE AND RESULTED IN THE SET ¿POPPING¿ AND LEAKING NORMAL SALINE. 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 22151312 ↗
• MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP EXTENSION SETS LEAKED. THE PROCESS STEP WAS UNKNOWN. 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 19660552 ↗
• MalfunctionNov 26, 2020Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S BLOOD WAS BACKING UP INTO THE FILTER OF A NON-DEHP EXTENSION SET, AND STARTED TO LEAK FROM THE EDGE OF THE FILTER. THE LOCATION OF THE LEAK WAS FURTHER DESCRIBED AS BLUE AND CLEAR PLASTIC PART THAT COME TOGETHER. THIS WAS FURTHER DESCRIBED BY THE CUSTOMER AS, ¿THE FILTER HAS THE BLUE CASING AND THE CLEAR CASING AND THE LEAKS CAME FROM THE EDGE BETWEEN THOSE CASING. NO CRACK NOTED.¿ THIS WAS IDENTIFIED WHILE IN USE. 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 10909428 ↗
• InjuryNov 5, 2020Backflow; Fluid/Blood Leak

  RECEIVED A CALL FROM NURSE THAT TPN FILTER APPEARED TO BE LEAKING. PHARMACIST WENT UP WITH REPLACEMENT AND TO INVESTIGATE FAILURE. BLOOD BACKED UP ALL THE WAY INTO THE FILTER FROM THE PATIENT'S PORT. WHEN FLUSHING SALINE FROM OPPOSITE END CAN SEE LEAKING AROUND THE FILTER DEVICE. NON-DEHP EXTENSION SET WITH 1.2 MICRON DOWNSTREAM FILTER TUBING SEEMS TO HAVE HAD A BREAK IN THE SEAL ALONG THE EDGES OF THE FILTER. CANNOT SEE ANY VISIBLE CRACKS IN THE PLASTIC. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10800966 ↗
• MalfunctionMar 7, 2019Complete Blockage; No Flow; Complete Blockage; No Flow

  IT WAS REPORTED THAT TWO (2) INTERLINK SOLUTION SETS WERE CLOGGED AND WOULD NOT FLOW. THIS WAS OBSERVED DURING INFUSION WITH 20% FAT EMULSIONS AS PART OF PARENTERAL NUTRITION. 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 8400557 ↗
• MalfunctionSep 11, 2018Improper Flow or Infusion; No Flow; Improper Flow or Infusion; No Flow

  IT WAS REPORTED THAT AN INTERLINK SOLUTION SET HAD AIR IN AN UNSPECIFIED LOCATION NEAR THE FILTER. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY FILLING THE SET WHICH STOPPED HALFWAY DURING INFUSION AND THERE WAS EXCESSIVE AMOUNT OF AIR COMING THROUGH THE FILTER. THIS EVENT OCCURRED 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 7866076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952074. One submission often covers many models, so check the product and lot details in each record.

• Z-0200-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H86