CLEARLINK 2C8857Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00085412046372), received between Jan 12, 2018 and Jan 27, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, VENTED PE-LINED SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING 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 24192760 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET WAS LEAKING. THE LEAK OCCURRED AT THE SITE WHERE THE TUBING ATTACHES TO A SPIKE ADAPTOR. THE LEAK WAS IMMEDIATELY NOTICED AFTER HANGING THE IV BAG. THE DEVICE CONTAINED TAXOL. 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 20487294 ↗
• MalfunctionOct 11, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED WHERE THE TUBING JOINS THE DRIP CHAMBER. THIS 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 20428955 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED PACLITAXEL FROM AN UNSPECIFIED LOCATION. THE LEAK OCCURRED DURING CHEMO 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 20161116 ↗
• MalfunctionMay 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED KEYTRUDA FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED UNDER THE MIXING HOOD. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19408758 ↗
• MalfunctionMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF VENTED PACLITAXEL SETS LEAKED HAZARDOUS DRUGS. THIS WAS OBSERVED 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 18841812 ↗
• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED RIGHT AROUND THE FILTER. THE ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP, BEFORE LEAVING THE INTRAVENOUS (IV) ROOM. 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 15251352 ↗
• MalfunctionAug 15, 2022No Flow; No Flow

  IT WAS REPORTED THAT TWO (2) VENTED PACLITAXEL SETS WOULD NOT ALLOW THE UNSPECIFIED SOLUTION TO FLOW. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225074 ↗
• MalfunctionJun 3, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CLAMP OF A VENTED PACLITAXEL SET FAILED TO PREVENT FLUID/DROPS FROM FALLING FROM THE FLUID CONTAINER WHEN FULLY ENGAGED. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593880 ↗
• MalfunctionJun 3, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CLAMP ON A VENTED PACLITAXEL SET FAILED TO PREVENT FLUID/DROPS FROM FALLING FROM THE FLUID CONTAINER WHEN FULLY ENGAGED. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593872 ↗
• MalfunctionJun 3, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CLAMP OF A VENTED PACLITAXEL SET FAILED TO PREVENT FLUID/DROPS FROM FALLING FROM THE FLUID CONTAINER WHEN FULLY ENGAGED. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593871 ↗
• MalfunctionMay 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT A VENTED PACLITAXEL SET LEAKED WHERE THE TUBING MEETS THE DRIP CHAMBER. THIS OCCURRED DURING PRIMING WITH SALINE BEFORE CHEMOTHERAPY WAS TO BE ADDED. THE SET WAS CONNECTED TO A NON-BAXTER CHEMO ADAPTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429865 ↗
• MalfunctionFeb 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A VENTED PACLITAXEL SET LEAKED. THE LEAK WAS OBSERVED FROM THE ¿WHITE CONNECTOR PIECE NEAR FILTER¿. IT WAS FURTHER REPORTED, THE CAUSE OF THE LEAK APPEARED TO BE FROM ¿DAMAGED TUBING¿; IT WAS ¿ALMOST LIKE THE WHITE BAND WAS CRIMPED TOO MUCH AND WEAKENED THE TUBING¿. THE ISSUE OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11350843 ↗
• MalfunctionFeb 9, 2021Fluid/Blood Leak; Material Protrusion/Extrusion; Fluid/Blood Leak; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE TUBING OF A VENTED PACLITAXEL SET WAS DAMAGED WHICH RESULTED IN A LEAK OF MEDICATION. THE DAMAGED TUBING WAS FURTHER DESCRIBED AS BEING CRIMPED WHICH WEAKENED THE TUBING. THIS ISSUE WAS IDENTIFIED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11301946 ↗
• MalfunctionDec 15, 2020No Flow; No Flow

  IT WAS REPORTED THAT THREE (3) VENTED PACLITAXEL SETS WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT WHEN THE SETS WERE HOOKED UP TO AN UNSPECIFIED PUMP, THE DRIP CHAMBER "LOCKS UP" AND ALL THE FLUID DRAINED INTO THE DRIP CHAMBER. THE NURSE WOULD OBTAIN NORMAL FLOW BY SQUEEZING THE DRIP CHAMBER. 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 11008371 ↗
• MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED FROM THE UNSPECIFIED LOCATION. THIS ISSUE WAS NOTED DURING 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 Consequences Or Impact To Patient

  MAUDE report 10809290 ↗
• MalfunctionJun 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED "ONE OR TWO" (1 OR 2) VENTED PACLITAXEL SETS WERE OBSERVED CRACKED AND LEAKING. IT WAS FURTHER SPECIFIED HE TUBING WAS CRACKED. THIS WAS NOTED DURING 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 Consequences Or Impact To Patient

  MAUDE report 8692281 ↗
• MalfunctionJan 12, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SOLUTION ADMINISTRATION SET DISCONNECTED CAUSING A LEAK. DURING SETUP AFTER PREPPING THE NEW IV SET AND BAG, THE SPIKE HAD SLIPPED OUT OF THE IV BAG; AFTER THE DOSE WAS HUNG. THE BAG DISCONNECTED AND A LEAK OCCURRED INSIDE THE DELIVERY BAG. IT WAS NOTED THE SPIKE WAS TOO SHORT AND FELL OUT. THE SET WAS BEING USED WITH A BAXTER BAG AND THE DEVICE WAS FILLED WITH AN UNSPECIFIED AMOUNT OF PACLITAXEL. 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 7186166 ↗

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