CLEARLINK 2C8858Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00085412071688), received between Jan 5, 2018 and Feb 25, 2025 — classified as 80 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (60 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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED DUE TO SEPARATION OF BONDED COMPONENTS (TUBING TO BUSHING). THE EVENT WAS FURTHER DESCRIBED AS A LEAK FROM THE "PUMP SEGMENT JOINT"; THE SET CONTAINED PACLITAXEL IN THE LINE. THIS WAS OBSERVED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463706 ↗
• MalfunctionJan 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK PACLITAXEL SET WAS ALTERED FROM THE UNDILUTED ETOPOSIDE USED. THE FILTER OF THE DEVICE WAS DAMAGED BY THE CHEMO. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230843 ↗
• MalfunctionJun 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED FROM THE 'INJECTION SITES'. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530204 ↗
• MalfunctionMay 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED AN UNKNOWN QUANTITY OF PACLITAXEL SETS LEAKED FROM UNSPECIFIED LOCATIONS DURING PATIENT USE. THESE WERE OBSERVED DURING USE. 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 19373291 ↗
• MalfunctionMay 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED AN UNKNOWN QUANTITY OF PACLITAXEL SETS LEAKED FROM UNSPECIFIED LOCATIONS DURING PATIENT USE. THESE WERE OBSERVED DURING USE. 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 19373288 ↗
• MalfunctionApr 26, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THE TUBING OF TWO (2) PACLITAXEL SETS LEAKED. THE TUBINGS "SEPARATED AT WHITE UMP SEGMENT AND SEPARATION OCCURRED BETWEEN BONDED COMPONENTS" WHICH RESULTED IN A LEAK. THE EVENT 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 19193622 ↗
• MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT OF A PACLITAXEL SET LEAKED FROM THE TUBING. THE LEAK WAS DISCOVERED DURING SET UP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968801 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET LEAKED DUE TO A SEPARATION OF BONDED COMPONENTS. THE LEAK OCCURRED ON THE PUMP SEGMENT OF THE TUBING. THIS OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606773 ↗
• MalfunctionSep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET WAS LEAKING FROM BELOW THE DRIP CHAMBER. THIS ISSUE OCCURRED WHILE THE PATIENT WAS CONNECTED FOR CHEMOTHERAPY 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 17699022 ↗
• MalfunctionJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED AT THE BOTTOM PORT (CLEARLINK) CAUSING A CHEMOTHERAPY SPILL. 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 17182999 ↗
• MalfunctionJun 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) PACLITAXEL SETS HAD LEAKAGE IN THE TUBING. THIS WAS DISCOVERED DURING PRIMING. THREE (3) SETS WERE FILLED WITH CHEMOTHERAPY AND ONE (1) SET WAS INJECTED WITH SALINE ONLY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107166 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED FROM 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 17089935 ↗
• MalfunctionMar 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED (A DROP OF LIQUID WAS NOTED BETWEEN DRIP CHAMBER AND TUBING). THE ISSUE WAS IDENTIFIED 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 16526096 ↗
• MalfunctionMar 1, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT A PACLITAXEL SET SEPARATED AT THE DRIP CHAMBER AND TUBING. THIS ISSUE OCCURRED ON THE HOSPITAL FLOOR WHILE THE NURSE WAS PREPARING TO SETUP THE SET PRIOR TO PATIENT USE. THIS WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460777 ↗
• MalfunctionDec 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED AT THE BOTTOM OF THE DRIP CHAMBER. THIS ISSUE WAS IDENTIFIED DURING CHEMOTHERAPY 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 15934102 ↗
• MalfunctionNov 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) PACLITAXEL SETS LEAKED. THE EVENTS OCCURRED IN THE PHARMACY DURING PREPARATION. THE LEAKS WERE OBSERVED FROM THE TUBING UNDER THE DRIP CHAMBER. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749671 ↗
• MalfunctionNov 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED FROM THE TUBING. THE SET HAD BEEN ATTACHED TO A PATIENT AND RESULTED IN A SIGNIFICANT AMOUNT OF DRUG LOSS ONTO THE PUMP, FLOOR, AND TREATMENT CHAIR. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THE DRUG HAD TO BE REPLACED AND THE CYTOTOXIC SPILL WAS CLEANED UP. 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 15726454 ↗
• MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS WERE LEAKING FROM THE TUBING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717326 ↗
• MalfunctionSep 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) PACLITAXEL SETS WERE LEAKING AROUND THE DRIP CHAMBER. THIS WAS OBSERVED DURING PRIMING WITH SALINE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494268 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS SPILLAGE OF CYTOTOXIC PRODUCT WHILE USING A PACLITAXEL SET. THE LEAK OCCURRED UNDER THE DRIP CHAMBER AND AT THE CONNECTION WITH THE TUBING FILTER. 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 15406456 ↗
• MalfunctionSep 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS SPILLAGE OF CYTOTOXIC PRODUCT WHILE USING A PACLITAXEL SET. 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 15382444 ↗
• MalfunctionAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF PACLITAXEL SETS EXPERIENCED LEAKING FROM UNSPECIFIED LOCATIONS; DESCRIBED AS ¿FROM THE BAG WITH DETAILS ON WHERE THE LEAK WAS COMING FROM TO BE SPECIFIED¿. THIS WAS OBSERVED DURING UNSPECIFIED PROCESS STEPS. 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 15276945 ↗
• MalfunctionAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED. THE ISSUE WAS IDENTIFIED 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 15276055 ↗
• MalfunctionJun 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED THE CHEMOTHERAPY DRUG (PACLITAXEL). THE LEAK WAS COMING FROM THE WHITE PUMP SEGMENT. THIS WAS IDENTIFIED AFTER HOOKING UP THE PATIENT AND DURING THE BEGINNING OF THE 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 14690110 ↗
• MalfunctionMay 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PACLITAXEL SET LEAKED WHERE THE DRIP CHAMBER MEETS THE TUBING. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH PACLITAXEL. THE TREATMENT WAS STOPPED IMMEDIATELY AND THERAPY WAS CONTINUED WITH A NEW SET. 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 14414091 ↗

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-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-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-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