INTERLINKRecalls & reported problems across all models

We found 10 models of INTERLINK by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2017 and Sep 24, 2026 — classified as 1 injury, 96 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (56 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

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

• INTERLINK 2C7558

  Set, administration, intravascular
  30 reports
• INTERLINK 2C6750H

  Set, blood transfusion
  18 reports
• INTERLINK 2C6425

  Set, administration, intravascular
  11 reports
• INTERLINK 2C7557

  Set, administration, intravascular
  10 reports
• INTERLINK 2C6401

  Set, administration, intravascular
  9 reports
• INTERLINK 2C6700

  Set, blood transfusion
  8 reports
• INTERLINK 2N3379

  Set, administration, intravascular
  6 reports
• INTERLINK 2N3399

  Set, administration, intravascular
  2 reports
• INTERLINK 2H6401

  Set, administration, intravascular
  2 reports
• INTERLINK 1C8581

  Set, administration, intravascular
  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 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886558 ↗
• MalfunctionAug 19, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326655 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED NORMAL SALINE SOLUTION "NEAR THE DRIP CHAMBER". THE EVENT WAS IDENTIFIED DURING THE FINAL PHYSICAL LINE CHECK PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25189162 ↗
• MalfunctionFeb 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHAMBER (BLOOD FILTER) OF AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED. THE ISSUE WAS NOTICED WHILE ADMINISTERING PRBC (PACKED RED BLOOD CELLS). 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 24401198 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED NEAR THE FILTER AND SOLUTION DRIPPED ON THE GROUND. THIS WAS OBSERVED AT A 15 MINUTE CHECK DURING PATIENT INFUSION WITH PLATELETS. THE TUBING WAS DISCONNECTED AND REMOVED FROM THE PATIENT TO RESOLVE THE ISSUE. 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 24350250 ↗
• MalfunctionJan 23, 2026

  RN ADMINISTERING PRBC [PACKED RED BLOOD CELLS] NOTED THAT CHAMBER OF BLOOD TUBING LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160700 ↗
• MalfunctionJan 20, 2026

  NO HARM TO PATIENT. PLATELETS WERE PRIMED AND HUNG ON PATIENT. AT 15 MINUTE CHECK, TUBING NEAR FILTER LEAKING AND DRIPPING ON TO GROUND. TUBING DISCONNECTED AND REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114680 ↗
• MalfunctionDec 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) INTERLINK SYSTEM VENTED SOLUTION SETS LEAKED FROM THE VENTED FILTER NEAR THE SPIKE. THIS WAS OBSERVED 36 HOURS INTO A 48-HOUR INFUSION. THE DEVICE CONTAINED BLINCYTO. 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 23922216 ↗
• MalfunctionDec 11, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF AN INTERLINK STRAIGHT TYPE BLOOD SET SEPARATED FROM THE DRIP CHAMBER. THE SET WAS SPIKED INTO THE BLOOD BAG (RBC) AND HUNG. WHILE PRIMING THE DRIP CHAMBER, THE INTRAVENOUS (IV) TUBING SEPARATED FROM THE DRIP CHAMBER, CAUSING BLOOD TO POUR FREELY FROM BOTH THE CHAMBER AND THE BAG UNTIL IT COULD BE RE-SPIKED WITH NEW STERILE BLOOD TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780412 ↗
• MalfunctionNov 14, 2025Contamination; Fluid/Blood Leak; Material Separation

  NURSE WAS ABOUT TO ADMINISTER PACKED RBC'S [RED BLOOD CELLS]. AFTER SPIKING THE BAG, NURSE WENT TO HANG AND PRIME DRIP CHAMBER. AS HE WAS PRIMING DRIP CHAMBER, IV TUBING SEPARATED FROM THE DRIP CHAMBER, CAUSING BLOOD TO POUR FREELY FROM CHAMBER AND BAG UNTIL IT COULD BE RE-SPIKED WITH NEW STERILE BLOOD TUBING. BLOOD CONTAMINATION OCCURRED OF IV PUMPS, IV POLE, IV POWER SHELF, PATIENT BED, AND FLOOR. CONTAMINATION DISINFECTED AND STERILIZED. IV TUBING NUMBER (01) 00085412068152 LOT (10) R24J19024

  Patient problems: Insufficient Information

  MAUDE report 23554090 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE HAD STRESS LINES. THIS WAS OBSERVED DURING VISUAL INSPECTION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066668 ↗
• MalfunctionSep 15, 2025Crack; Crack

  IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE HAD A CRACK ON THE UPPER PART OF THE PLASTIC CASING. THIS WAS OBSERVED OUT OF THE BOX PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058793 ↗
• MalfunctionSep 5, 2025Crack; Crack

  IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE HAD STRESS LINES. THE ISSUE WAS FOUND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986525 ↗
• MalfunctionSep 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (02) INTERLINK SYSTEM INJECTION SITES WERE FOUND TO HAVE CRACKS ON THE UPPER PART OF THE PLASTIC CASING OF THE SEPTUM, AROUND THE PIERCING. THE CRACKS RESULTED IN LEAK. THE ISSUE WAS FOUND DURING SET-UP; HOWEVER, MEDICATION WAS NOT INVOLVED AT THIS STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983862 ↗
• MalfunctionSep 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) INTERLINK SYSTEM INJECTION SITES WERE FOUND TO HAVE CRACKS ON THE UPPER PART OF THE PLASTIC CASING OF THE SEPTUM AROUND THE PIERCING, WHICH RESULTED IN A LEAK. THE ISSUE WAS FOUND DURING SET-UP; HOWEVER, MEDICATION WAS NOT INVOLVED AT THIS STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983706 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• MiniCap3 models · 3,423 reports · 7 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports