INTERLINKRecalls & reported problems across all models

We found 17 models of INTERLINK by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Sep 28, 2026 — classified as 9 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (66 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INTERLINK problems

INTERLINK models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INTERLINK 2N3328

  Set, administration, intravascular
  46 reports
• INTERLINK 2N3339

  Set, administration, intravascular
  14 reports
• INTERLINK 2C6671

  Set, administration, intravascular
  10 reports
• INTERLINK 1C8740

  Filter, infusion line
  10 reports
• INTERLINK 2N3326

  Set, administration, intravascular
  9 reports
• INTERLINK 2C1103

  Set, administration, intravascular
  7 reports
• INTERLINK 2N3374

  Set, administration, intravascular
  7 reports
• INTERLINK 2N3378

  Set, administration, intravascular
  7 reports
• INTERLINK 2C6723

  Set, blood transfusion
  5 reports
• INTERLINK 2C7451

  Set, administration, intravascular
  3 reports
• INTERLINK 2C6720

  Set, blood transfusion
  3 reports
• INTERLINK 1C8333

  Set, administration, intravascular
  2 reports
• INTERLINK 1W5000

  Set, administration, intravascular
  2 reports
• INTERLINK 2N3327

  Set, administration, intravascular
  1 report
• INTERLINK 2N3333

  Filter, infusion line
  1 report
• INTERLINK 2N3340

  Set, administration, intravascular
  1 report
• INTERLINK 2C6921

  Stopcock, i.V. Set
  1 report

Recent INTERLINK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Disconnection; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921516 ↗
• InjurySep 7, 2026Disconnection; Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50651298 ↗
• MalfunctionAug 21, 2026Backflow; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383043 ↗
• MalfunctionAug 6, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161152 ↗
• 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 ↗
• MalfunctionMay 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF FOUR (4) NON-DEHP T-CONNECTOR EXTENSION SETS WAS "CUT OFF". THIS WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175959 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

  PRODUCT WAS REPORTED A Y-TYPE BLOOD/SOLUTION SET (WITH LARGE STANDARD BLOOD FILTER AND PRESSURE PUMP) LEAKED BLOOD PRODUCT FROM THE BASE OF THE PRESSURE PUMP. THIS WAS OBSERVED DURING A PROCEDURE. 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 25154077 ↗
• 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 ↗
• InjuryMar 3, 2026Backflow; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK NEAR THE DISTAL END OF AN INTERLINK NON-DEHP T-CONNECTOR EXTENSION SET WHICH RESULTED IN THE PATIENT¿S BLOOD BACKING UP INTO THE LINE AND LEAKING FROM THE CRACKED DISTAL END. DURING USE OF THE INTERLINK SET, IT WAS OBSERVED THAT BLOOD BACKED UP IN THE LINE, AND WHEN STAFF ATTEMPTED TO FLUSH THE SET, A MIXTURE OF BLOOD AND SALINE WAS OBSERVED LEAKING FROM A CRACK NEAR THE DISTAL END OF THE DEVICE. THE CRACK WAS LOCATED ON THE DISTAL END COMPONENT/HARD PLASTIC WHERE THE FLUSH CONNECTS. IT WAS ESTIMATED THAT THE NEONATE PATIENT LOST APPROXIMATELY 1¿2 ML OF BLOOD. THE PATIENT DID RECEIVE A BLOOD TRANSFUSION LATER THAT DAY; HOWEVER, THIS WAS ATTRIBUTED TO THE PATIENT¿S UNDERLYING CONDITION AND NOT NECESSARILY RELATED TO THE SMALL VOLUME OF BLOOD LOSS FROM THE DEVICE ISSUE, THOUGH IT MAY HAVE CONTRIBUTED MARGINALLY TO TIMING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24503299 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM SOLUTION SETS LEAKED DUE TO HOLE IN THE TUBING. THIS OCCURRED WHILE PRIMING THE TUBING WITH UNSPECIFIED MEDICATION IN THE INTENSIVE CARE UNIT. 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 24485069 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET LEAKED FROM THE T-CONNECTOR. THE DEVICE WAS CONNECTED TO A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER). THE DEVICE CONTAINED IVF (INTRAVENOUS FLUIDS). 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 24484013 ↗
• 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 ↗
• MalfunctionFeb 2, 2026

  T-CONNECTOR DIRECTLY CONNECTED TO THE PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] HAS A VISIBLE, SLOWLY LEAKED IVF [INTRAVENOUS FLUIDS].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229420 ↗
• 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 ↗
• MalfunctionDec 18, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT AN INTERLINK NON-DEHP T-CONNECTOR EXTENSION SET HAD A CONNECTION ISSUE. THE CONNECTION ISSUE WAS DESCRIBED AS THE SET FAILED TO CONNECT TO THE NEEDLE AS THERE WAS A DEFORMITY OBSERVED OF THE LUER LOCK. 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 23838813 ↗

Other Baxter International Inc. products

• CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
• ONE-LINK12 models · 638 reports · 1 recall
• CLEARLINK19 models · 359 reports · 4 recalls
• INTRAVIA7 models · 455 reports
• CLEARLINK/DUO-VENT3 models · 150 reports
• LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
• Arthromatic/Uromatic3 models · 59 reports
• PrismaSATE2 models · 1 reports · 1 recall