INTERLINK 2C6700Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00085412068152), received between Apr 18, 2018 and Dec 11, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

10 other recalls cover devices cleared under the same FDA submission (K993120); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 15, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AN INTERLINK STRAIGHT TYPE BLOOD SET WOULD NOT CONNECT TO A BAG OF PLATELETS. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿CONNECTOR ON END OF TUBING WOULD NOT CONNECT TO MALE ADAPTER PLUG, OR ANY OTHER PORT ON ANY ANOTHER TUBING TRIED¿. THIS ISSUE WAS IDENTIFIED DURING PRIMING. TO RESOLVE THIS ISSUE, A NEW SET WAS USED AND WORK APPROPRIATELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802589 ↗
• MalfunctionMar 17, 2022Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK STRAIGHT TYPE BLOOD SET LEAKED DURING INFUSION OF BLOOD. ALL CLAMPS, INCLUDING THE CENTRAL LINE CLAMP, WERE OPEN. THE BOTTOM INJECTION SITE PORT WAS CAPPED WITH A GREEN ALCOHOL CAP. DURING INFUSION, AN ESTIMATED 22CC OF BLOOD BACKFLOWED OUT OF THE INJECTION SITE PORT AND ONTO THE PATIENT AND BED. THE REST OF BLOOD IN THE TUBING WAS TRANSFERRED BACK INTO THE BLOOD BAG, AND A NEW SET WAS UTILIZED TO COMPLETE THE INFUSION WITH NO ISSUES NOTED. 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 13794848 ↗
• MalfunctionFeb 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK STRAIGHT TYPE BLOOD SET WAS LEAKING FROM THE INJECTION SITE PORT. BLOOD WAS HUNG UTILIZING THE BLOOD SET AND IT WAS OBSERVED THAT BLOOD BACK FLOWED OUT OF THE INJECTION SITE PORT. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. TO RESOLVE THE ISSUE, A NEW SET WAS UTILIZED WITH NO ISSUES. 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 13488360 ↗
• MalfunctionSep 30, 2019No Flow; No Flow

  IT WAS REPORTED THAT THE LINES OF AN UNSPECIFIED QUANTITY OF INTERLINK BLOOD RECIPIENT SETS WERE UNABLE TO BE CLEARED. IT WAS FURTHER REPORTED THAT THE TUBING WAS TOO LONG. THIS WAS IDENTIFIED DURING PATIENT 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 9136000 ↗
• MalfunctionApr 23, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THE SPIKE OF AN INTERLINK STRAIGHT TYPE BLOOD SET BROKE OFF IN THE BLOOD TRANSFUSION BAG, LEADING TO A LEAK. THIS OCCURRED WHEN THE NURSE SPIKED THE BAG DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8541743 ↗
• MalfunctionApr 18, 2018Break; Break

  IT WAS REPORTED THAT AN INTERLINK BLOOD SET FILTER BROKE OFF DURING PATIENT USE. THERE WAS NO REPORT OF A LEAK. 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 7441451 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993120. One submission often covers many models, so check the product and lot details in each record.

• Z-0193-05 · Apr 28, 2004 · Terminated
  Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows
• Z-1177-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776; Baxter He
• Z-1176-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Dee
• Z-1162-03 · Jul 16, 2003 · Terminated
  Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Mal
• Z-1175-03 · Jul 16, 2003 · Terminated
  Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthc
• Z-1171-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115'', 80 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare Corporation, Deerfield, IL 60015 U
• Z-1178-03 · Jul 16, 2003 · Terminated
  Fenwal 3-Lead Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 82'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C7784; Baxter Healt
• Z-1172-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C
• Z-1161-03 · Jul 16, 2003 · Terminated
  Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxte
• Z-1160-03 · Jul 16, 2003 · Terminated
  Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Cor