CLEARLINK 2R8401Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00085412565767), received between Sep 12, 2019 and May 22, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (58 reports).

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

13 other recalls cover devices cleared under the same FDA submission (K112893, K180739); 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 16, 2026.

Recalls naming this device

1. Feb 8, 2024Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

   Z-1291-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP SOLUTION SET LEAKED AT THE CLEARLINK INJECTION SITE; FURTHER DESCRIBED AS "LEAK AT THE BASE OF THE AIR CHAMBER ". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25258595 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO (02) CLEARLINK SYSTEM, NON DEHP SOLUTION SETS HAD A CRACK/DAMAGE AT THE BEGINNING OF THE TUBING NEAR THE DRIP CHAMBER, WHICH RESULTED IN LEAKAGE OF THE SOLUTION (UNSPECIFIED) TO BE ADMINISTERED. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376943 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP SOLUTION SET LEAKED UNDER THE DRIP CHAMBER. THE LEAK WAS ASSOCIATED WITH A SEPARATION OF BONDED COMPONENTS AT THE JUNCTION POINT OF THE DRIP CHAMBER AND TUBING. THE ISSUE WAS FOUND DURING FLUID PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961418 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THE LEAK 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 20170153 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM NON-DEHP I.V. CATHETER EXTENSION SETS LEAKED AN UNSPECIFIED CHEMOTHERAPY SOLUTION. THE LEAK WAS OBSERVED AT THE JUNCTION BETWEEN THE DRIP CHAMBER AND TUBING. 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 20033063 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM, NON-DEHP SOLUTION SETS LEAKED AND THERE WAS CHEMOTHERAPY EXPOSURE. 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 20002276 ↗
• MalfunctionAug 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE TUBING OF A CLEARLINK SYSTEM, NON-DEHP SOLUTION SET WHICH RESULTED IN A FLUID LEAK. 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 19906399 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. 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 19234624 ↗
• MalfunctionApr 12, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM, NON-DEHP SOLUTION SET HAD BEEN ALARMING "UPSTREAM OCCLUSION" AND "MAX AIR DETECTED" ON THE PUMP. THIS WAS OBSERVED DURING INFUSIONS WITH 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 19101433 ↗
• MalfunctionApr 12, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM, NON-DEHP SOLUTION SET HAD BEEN ALARMING "UPSTREAM OCCLUSION" AND "MAX AIR DETECTED" ON THE PUMP. THIS WAS OBSERVED DURING INFUSIONS WITH 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 19101431 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED FROM THE TUBING. THERE WAS A CUT/SLICE IN THE SOFT TUBING. 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 18792281 ↗
• MalfunctionFeb 26, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP SOLUTION SET LEAKED AT THE DRIP CHAMBER DURING PRIME. ADDITIONALLY, A SEPARATION WAS OBSERVED AT THE JUNCTION BETWEEN THE TUBING AND THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784118 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS LEAKING FROM THE DRIP CHAMBER. THE LEAK WAS DISCOVERED BY THE NURSE AND WAS BROUGHT BACK TO THE PHARMACY. THE DEVICE HAD CHEMOTHERAPY IN THE LINE (VINCRISTINE). 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 18459944 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE TUBING AND THE DRIP CHAMBER OF A CLEARLINK SYSTEM SOLUTION SET. THE LEAK WAS DISCOVERED WHILE PRIMING THE SET PRIOR TO PATIENT USE. THE TECHNICIAN PULLED ON TUBING AND RESULTED IN A SEPARATION BETWEEN THE TUBING AND DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459327 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP SOLUTION SETS LEAKED WHERE THE DRIP CHAMBER MEETS THE LINE. 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 18459005 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM SOLUTION SETS WERE LEAKING WHERE THE DRIP CHAMBER MEETS THE TUBING. THE LEAKS WERE DISCOVERED WHILE THE PHARMACY PRIMES THE LINES DURING INTERNAL TESTING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455914 ↗
• MalfunctionJan 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP SOLUTION SET LEAKED FROM THE DRIP CHAMBER. THIS WAS DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444752 ↗
• MalfunctionJan 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WAS LEAKING WHERE THE TUBING GOES INTO THE SPIKE. 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 18436517 ↗
• MalfunctionDec 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM, NON-DEHP SOLUTION SETS LEAKED FROM THE DRIP CHAMBER AND TUBING CONNECTION POINT. THIS WAS DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419731 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM, NON-DEHP SOLUTION SETS LEAKED FROM CONNECTION BETWEEN THE DRIP CHAMBER AND TUBING. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412434 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM NON-DEHP SOLUTION SETS LEAKED FROM THE DRIP CHAMBER. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS A SEPARATION OF THE DRIP CHAMBER AND TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411755 ↗
• MalfunctionDec 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP SOLUTION SET LEAKED WHERE THE DRIP CHAMBER MEETS THE TUBING. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399976 ↗
• MalfunctionDec 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM, NON-DEHP SOLUTION SET LEAKED WHERE THE DRIP CHAMBER MEETS THE TUBING. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399876 ↗
• MalfunctionDec 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SIX (6) CLEARLINK SYSTEM, NON-DEHP SOLUTION SETS LEAKED AT THE JUNCTION OF THE DRIP CHAMBER AND TUBING. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372917 ↗
• MalfunctionDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SIX (6) NON-DEHP CLEARLINK SOLUTION SETS LEAKED FROM THE DRIP CHAMBER. THIS WAS NOTICED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332581 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112893, K180739. One submission often covers many models, so check the product and lot details in each record.

• Z-0190-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
• Z-0203-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-i
• Z-0199-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
• Z-0197-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
• Z-0198-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
• Z-0202-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
• Z-0201-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
• Z-0191-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
• Z-1010-2025 · Dec 20, 2024 · Open, Classified
  Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
• Z-1009-2025 · Dec 20, 2024 · Open, Classified
  Baxter Solution Set with Duo-Vent Spike, REF 2R8404
• Z-1653-2022 · Aug 9, 2022 · Terminated
  Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
• Z-0099-2014 · Sep 4, 2013 · Terminated
  Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation,
• Z-1271-2013 · Mar 28, 2013 · Terminated
  A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte