CLEARLINK 2R8858Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00085412565774), received between Jul 2, 2019 and Mar 12, 2026 — classified as 129 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (109 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0203-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026No Flow

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET DID NOT RUN ONCE SPIKED WITH TAXOL. THE ISSUE WAS NOTICED DURING PATIENT USE. THE DEVICE WAS PRIMED WITH SALINE. 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 24578952 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, PE-LINED SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THE FLUID AND AIR WERE FREELY FLOWING/EXCHANGING IN TUBING EVEN WITH THE ROLLER CLAMP LOCKED AND A NON BAXTER FEMALE ADAPTOR ATTACHED AT THE END. THIS OCCURRED AFTER PRIMING WITH FAM TRASTUZUMAB DERUXTECAN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569355 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, PE-LINED SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS DEVICE CONTAINED DOCETAXEL. THIS OCCURRED AFTER PRIMING WHEN THE CHEMOTHERAPY WAS ADDED TO THE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569245 ↗
• MalfunctionFeb 25, 2026No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF CLEARLINK SYSTEM PE-LINED SOLUTION SETS HAD DIFFICULTY RUNNING IVIG (INTRAVENOUS IMMUNOGLOBULIN) AND ALBUMIN. A PUMP WAS USED IN CONJUNCTION WITH THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24448802 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT LEAST ONE CLEARLINK, PACLITAXEL SET LEAKED FROM THE BOTTOM OF THE DRIP CHAMBER. THIS WAS OBSERVED AT THE END OF THE TAXOL 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 23934177 ↗
• MalfunctionDec 5, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE WRITING ON THE PRIMARY PACKAGE LABEL OF UNSPECIFIED UNITS OF CLEARLINK SYSTEM, PE-LINED SOLUTION SETS WAS SMEARING. THIS OCCURRED WHILE THE PRODUCTS WERE WIPED WITH ISOPROPYL ALCOHOL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725785 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET WAS LEAKING FROM BETWEEN THE FILTER AND THE SEGMENT OF THE TUBING LOADED INTO THE PUMP. THE LEAK WAS OBSERVED WHILE UNSPECIFIED MEDICATION WAS INFUSING. 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 23347781 ↗
• MalfunctionSep 18, 2025No Flow; No Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM PE-LINED SOLUTION SET HAD NO FLOW THROUGH THE TUBING. THIS WAS OBSERVED WHEN THE TUBING WAS USED ON THE IV (INTRAVENOUS) PUMP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089963 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM PE-LINED SOLUTION SET LEAKED FROM THE WHITE BAND. THIS WAS OBSERVED WHILE THE SET WAS HANGING. THE DEVICE CONTAINED UNSPECIFIED CHEMO. 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 22728832 ↗
• MalfunctionJul 31, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK, PACLITAXEL SET HAD A HOLE. THIS OCCURRED DURING PRIMING THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680870 ↗
• MalfunctionMay 15, 2025Fluid/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 AND SEPARATED AT THE BOTTOM OF MICRON FILTER WHERE IT CONNECTS TO REMAINING LINE. THIS OCCURRED DURING USE. THE DEVICE CONTAINED 20 MG DEXAMETHASONE. 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 22030831 ↗
• MalfunctionJan 9, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER OF TWO (2) CLEARLINK PACLITAXEL SETS LEAKED AT THE FILTER. THERE WAS A CRACK/BREAK IN THE FILTER COMPONENT. THE DEVICES CONTAINED ETOPOSIDE SOLUTION. THIS OCCURRED WHILE INFUSING ETOPOSIDE. 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 21114177 ↗
• MalfunctionJan 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FILTER OF A CLEARLINK PACLITAXEL SET WAS ALTERED FROM THE DRUG (ETOPOSIDE) USED. THE FILTER OF THE DEVICE WAS DAMAGED BY THE CHEMO. THIS WAS OBSERVED DURING FINAL INSPECTION AFTER LINE INSTALLATION ON THE MINI BAG PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106703 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET LEAKED FROM THE TUBING. THIS OCCURRED WHILE TITRATING 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 20667839 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET LEAKED RIGHT UNDER THE DRIP CHAMBER, "WHERE THE LINE CONNECTS". THIS OCCURRED WHILE PRIMING THE TUBING WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667291 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET LEAKED UNDERNEATH THE DRIP CHAMBER. THIS OCCURRED WHILE PRIMING THE TUBING WITH SALINE. A NEW SET WAS USED TO CONTINUE PREPARATION WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665636 ↗
• MalfunctionNov 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET WAS LEAKING FROM RIGHT UNDER THE DRIP CHAMBER WHERE THE TUBING CONNECTS. THE LEAK WAS DISCOVERED WHILE PRIMING THE SET WITH SALINE SOLUTION. TO RESOLVE THIS ISSUE, A NEW SET WAS PRIMED WITH NO ISSUES NOTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592203 ↗
• MalfunctionAug 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK, PACLITAXEL SET WAS DAMAGED; THE SET WAS CUT. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995741 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET LEAKED FROM THE FILTER. DURING A PACLITAXEL INFUSION THE NURSE WAS PERFORMING BLOOD RETURN CHECKS AND NOTED APPROXIMATELY 30 ML OF CLEAR LIQUID UNDER CHEMOTHERAPY BAG. THE INFUSION WAS STOPPED WITH 149 ML/98.6 MG REMAINING OF 400 MG PACLITAXEL BAG. THE PATIENT CONFIRMED THEY HAD NOT EXITED THE BED NOR HAD ANYONE WALKED THROUGH THE SPILL AREA. 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 19810938 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET LEAKED FROM THE FILTER. THE TUBING WAS NOTED TO BE CONTINUALLY/SLOWLY DRIPPING CHEMOTHERAPY AT THE FILTER SITE. THIS OCCURRED 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 19799954 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET LEAKED AT THE BASE OF THE DRIP CHAMBER, AT THE JOINT WHERE IT MEETS THE TUBING. THIS WAS NOTICED DURING PRIMING IN THE HOOD. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514718 ↗
• MalfunctionMay 21, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF UNDERINFUSIONS OCCURRED DURING THE USE OF CLEARLINK, PACLITAXEL SETS DURING INFUSION. IT WAS OBSERVED THAT THERE WERE MULTIPLE INCIDENTS OF TAXOL INFUSING TOO SLOW AND RUNNING 30 MINUTES TO 1 HOUR 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 19367116 ↗
• MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET LEAKED AT THE FILTER DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH EPCOH (ETOPOSIDE, PREDNISONE, VINCRISTINE, CYCLOPHOSPHAMIDE, AND DOXORUBICIN) SOLUTION. 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 19310565 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET LEAKED FROM THE DRIP CHAMBER. THIS WAS OBSERVED DURING PATIENT INFUSION WITH A CHEMOTHERAPY DRUG. THE TREATMENT WAS STOPPED TO RESOLVE THE EVENT. 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 19234569 ↗
• MalfunctionMar 14, 2024Break; Fluid/Blood Leak; Protective Measures Problem; Break; Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A CLEARLINK, PACLITAXEL SET LEAKED FROM "ONE OF THE SPLICES" (PUMP SEGMENT/BUSHING); THERE WAS A SMALL OPENING IN THE SPLICED AREA. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH TAXOL ON AN UNSPECIFIED PUMP. THE ISSUE WAS FURTHER DESCRIBED AS, "THE TAXOL STARTING SPRAYING OUT OF THE SPLICED AREA ABOVE THE CLAMP" AND THE PUMPED ALARMED AN AIR IN LINE ALARM. A NEW SET WAS USED TO CONTINUE TREATMENT AND A SPILL KIT USED TO CLEAN UP THE LEAK. THE NURSE WAS EXPOSED TO THE MEDICATION ON THEIR HANDS; HOWEVER, THE NURSE WASHED THEIR HANDS WITH NO FURTHER 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 18904637 ↗