INTERLINK 2C7558Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00085412036380), received between Jan 15, 2018 and Sep 24, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, 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 ↗
• MalfunctionAug 14, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT THERE WERE UNDERINFUSION OF SOLUTION DURING USE OF AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS; FURTHER DESCRIBED AS "OVERFILL LEFT IN IV BAGS". THIS WAS OBSERVED DURING PATIENT INFUSION ON A PUMP THAT WAS SCHEDULED FOR OVER 4 HOURS. APPROXIMATELY 40ML OF OVERFILL VOLUME REMAINED IN THE INTRAVENOUS BAGS THAT WERE SPIKED TO NON-BAXTER DEVICES. 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 19984785 ↗
• MalfunctionApr 2, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN UNDERINFUSION OF MEDICATION TO THE PATIENT OCCURRED WHILE USING A PACLITAXEL SET. THE EXPECTED THERAPY TIME WAS 3 HOURS; HOWEVER, THE BAG WAS NOT EMPTY AFTER 3 HOURS. THE INFUSION LASTED AN EXTRA 30 ¿ 40 MINUTES LONGER THAN EXPECTED. 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 19023427 ↗
• MalfunctionMar 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET WAS LEAKING FROM THE FILTER. THE LEAK WAS DISCOVERED AT THE END OF PATIENT TREATMENT. 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 19006812 ↗
• MalfunctionMar 12, 2024Filling Problem; Air/Gas in Device; Filling Problem; Air/Gas in Device

  IT WAS REPORTED THAT UNDER INFUSIONS OCCURRED AND THERE WAS AIR IN THE TUBING DURING THE USE OF EIGHT (8) PACLITAXEL SETS. DURING INFUSIONS, THERE WERE 8 INSTANCES WHERE ADDITIONAL THERAPY TIME WAS REQUIRED, RANGING FROM 30 TO 60 MINUTES, WITH DIFFERENT MEDICATIONS. ADDITIONALLY, THE TUBING WAS MORE SUSCEPTIBLE TO LARGE AIR BUBBLES DURING THE PRIMING PROCESS. 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 18886539 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT THE FILTER OF A PACLITAXEL SET BROKE APART FROM THE CHAMBER. THIS EVENT OCCURRED DURING THE PRIMING PROCESS. IT WAS NOT SPECIFIED IF THERE WAS PATIENT INVOLVEMENT. 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 18886252 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS LEAKED AFTER CONNECTING AND PRIMING TO INTRAVENOUS BAGS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876153 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET TPN (TOTAL PARENTERAL NUTRITION) TUBING LEAKED FROM AN UNSPECIFIED LOCATION. 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 18606601 ↗
• MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PACLITAXEL SET LEAKED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCESS STEP. 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 17118821 ↗
• MalfunctionJun 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED AT THE CONNECTION BETWEEN THE TUBING AND THE DRIP CHAMBER. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 17107032 ↗
• MalfunctionMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS LEAKED AT THE CONNECTION BETWEEN THE TUBING AND THE DRIP CHAMBER. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007339 ↗
• MalfunctionMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS LEAKED AT THE CONNECTION BETWEEN THE TUBING AND THE DRIP CHAMBER. THIS WAS IDENTIFIED DURING PATIENT 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 17007338 ↗
• MalfunctionMay 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) PACLITAXEL SETS WERE LEAKING WHERE THE TUBING CONNECTS TO THE DRIP CHAMBER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. 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 16941243 ↗
• MalfunctionMay 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED IN AN UNKNOWN LOCATION. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 16911538 ↗
• MalfunctionApr 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS LEAKED FROM THE AREA JUST BELOW THE FILL DRIP CHAMBER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. 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 16807309 ↗
• MalfunctionApr 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS LEAKED. THE LEAK WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. 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 16683611 ↗
• MalfunctionMar 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE UNSPECIFIED QUANTITY OF PACLITAXEL SETS WERE LEAKING BELOW THE DRIP CHAMBER. THE LOCATION OF THE LEAK WAS FURTHER DESCRIBED AS IN THE AREA WHERE THE TUBING GOES INTO THE DRIP CHAMBER. THIS WAS OBSERVED DURING PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537546 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED FROM A "COUPLE DIFFERENT SITES IN THE TUBING". THE ISSUE 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 16487062 ↗
• MalfunctionFeb 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS LEAKED FROM THE DRIP CHAMBER. THE ISSUE WAS IDENTIFIED DURING SET UP IN THE ONCOLOGY UNIT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16357563 ↗
• MalfunctionFeb 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY [AT LEAST ONE(1)] OF PACLITAXEL SETS LEAKED FROM THE DRIP CHAMBER. THE ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328805 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED FROM THE CHAMBER. THE ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759528 ↗
• MalfunctionJun 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED FROM WHERE THE DRIP CHAMBER CONNECTS TO THE TUBING. THE DEVICE WAS USED WITH PACLITAXEL DURING PATIENT 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 14633728 ↗
• MalfunctionJun 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A PACLITAXEL SET WAS LEAKING FROM WHERE THE DRIP CHAMBER CONNECTS TO THE TUBING. THE LEAK WAS OBSERVED DURING PATIENT INFUSION OF CHEMOTHERAPY. 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 14633009 ↗

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-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-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-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