INTERLINK 2C7557Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412036373), received between Apr 16, 2018 and Dec 30, 2025 — classified as 10 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K160007, K981792); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• 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 ↗
• MalfunctionJun 18, 2024Crack; Crack

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET HAD A CRACK IN THE TUBING RESULTING IN A CHEMOTHERAPY SPILL. THIS WAS OBSERVED WHEN THE CHEMOTHERAPY WAS HUNG AND PUT THROUGH AN UNSPECIFIED INTRAVENOUS (IV) PUMP. 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 19559553 ↗
• MalfunctionApr 23, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A VENTED PACLITAXEL SET CRACKED. THIS WAS OBSERVED DURING SETUP, WHEN CHEMOTHERAPY WAS HUNG AND THE SET WAS PUT THROUGH THE INTRAVENOUS (IV) PUMP; THE TUBING STARTED TO CRACK RESULTING IN LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168626 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) VENTED PACLITAXEL SETS WERE LEAKING. THE LEAK WAS FURTHER DESCRIBED AS, ¿LEAKED DILUENT THROUGH THE WHITE TUBING CONNECTOR PIECE ADJACENT TO THE FILTER¿. THE LEAKS OCCURRED WHILE PRIMING THE SETS WITH DILUTANT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311266 ↗
• MalfunctionFeb 9, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF VENTED PACLITAXEL SETS HAD BUBBLES WHICH IS INDICATIVE OF AIR IN THE LINE. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSIONS. 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 11302606 ↗
• MalfunctionAug 14, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED DUE TO "A SMALL HOLE IN THE TUBING FROM WHERE THE CLAMP WAS". THIS ISSUE WAS IDENTIFIED AFTER PRIMING WHEN THE NURSE WAS SETTING UP THE INFUSION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407793 ↗
• MalfunctionJun 4, 2020No Flow; No Flow

  IT WAS REPORTED THAT A QUANTITY (AT LEAST SEVEN) OF VENTED PACLITAXEL SETS WOULD NOT FLOW AFTER SPIKING TO UNKNOWN BAGS. THIS WAS DISCOVERED DURING MIXING IN THE PHARMACY. THERE WERE NO SIGNS OF PHYSICAL DAMAGE TO THE PRODUCT OR SHIPPING PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10119540 ↗
• MalfunctionFeb 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A VENTED PACLITAXEL SET LEAKED IN CONJUNCTION WITH A 250ML VIAFLO BAG. THE LEAK WAS OBSERVED FROM "WHERE THE SPIKE WAS INSERTED INTO THE BAG". THIS EVENT WAS IDENTIFIED DURING 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 9765265 ↗
• MalfunctionApr 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED. DURING PATIENT INFUSION WITH DOCETAXEL (RATE OF 262ML OVER ONE HOUR), A LEAK WAS OBSERVED ¿AROUND THE FILTER AT THE END OF THE FILTER¿. THE EVENT OCCURRED APPROXIMATELY 40 MINUTES INTO THE INFUSION VIA AN UNSPECIFIED PUMP. THE DRUG LEAKED ONTO THE FLOOR UNDER THE BAG. A CHEMO SPILL KIT WAS USED FOR CLEANUP. THERE WAS NO UNINTENDED DRUG EXPOSURE TO THE PATIENT OR CLINICIAN. 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 7432878 ↗
• MalfunctionApr 16, 2018Cut In Material; Cut In Material

  IT WAS REPORTED THAT THE BLUE SLIDE CLAMP OF A VENTED PACLITAXEL SET SEVERED THE TUBING WHICH RESULTED IN A LEAK. THE SLIDE CLAMP SEVERED THE TUBING DURING PATIENT SETUP. THE LINE HAD BEEN PRIMED AND THE PATIENT WAS CONNECTED FOR THERAPY WHEN THE SEVERED TUBING WAS IDENTIFIED. 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 7432504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160007, K981792. One submission often covers many models, so check the product and lot details in each record.

• Z-0618-2007 · Feb 16, 2007 · Terminated
  Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, L
• Z-0619-2007 · Feb 16, 2007 · Terminated
  Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection
• Z-0620-2007 · Feb 16, 2007 · Terminated
  Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer
• 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-1158-03 · Jul 16, 2003 · Terminated
  Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer Activated Valve, Male Luer Lock