CLEARLINK/CONTINU-FLO/DUO-VENT 2R8538Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00085412676647), received between Apr 7, 2022 and Sep 17, 2026 — classified as 1 injury, 69 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (46 reports).

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

5 other recalls cover devices cleared under the same FDA submission (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 18, 2026.

Recalls naming this device

1. Dec 20, 2024Class IIOpen, Classified

   Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

   Z-1010-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811881 ↗
• MalfunctionAug 13, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241125 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239958 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  It was reported that a CLEARLINK System Solution Set with DUO-VENT Spike leaked at the blue vent. The issue was identified after priming with Normal Saline (NS). The process step at which the issue occurred was not specified. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201845 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP SOLUTION SET LEAKED 5 MINUTES INTO PATIENT INFUSION. THE LOCATION OF THE LEAK WAS DESCRIBED AS "PROXIMAL TO THE PATIENT CONNECTION SITE OF THE LONG INFUSION 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 25396324 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE LEAKED AT THE SPIKE AIR VENT. THE ISSUE WAS IDENTIFIED DURING SPIKING OF A NORMAL SALINE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284841 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DRUG BEGAN DRIPPING FROM THE VENT OF A CLEARLINK SYSTEM - NON-DEHP SOLUTION SET WHEN THE DRUG BAG WAS SPIKED. 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 25192310 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET FELL APART. THE ISSUE OCCURRED WHILE SETTING UP HAZARDOUS DRUG FLUSH LINE DURING INFUSION LINE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125386 ↗
• MalfunctionMay 7, 2026Complete Blockage

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET WAS CLOGGED DURING PATIENT INFUSION WITH DOCETAXEL. THE Y SITE (MALE LUER LOCK ADAPTER VALVE) WAS CLOGGED OR WOULD NOT INFUSE THROUGH THE Y SITE, WHERE THE SHORT SET WAS CONNECTED. THE PRIMARY SET WAS REPLACED, CONNECTED THE SHORT SET TO THE NEW PRIMARY TUBING, AND THE CHEMOTHERAPY WAS ABLE TO INFUSE. 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 25109369 ↗
• MalfunctionApr 29, 2026Failure to Infuse

  IT WAS REPORTED THAT A CLEARLINK SYSTEM NON DEHP SOLUTION SET HAD NO FLOW DURING PATIENT INFUSION. THE PRIMARY SET WAS PRIMED WITH NORMAL SALINE (NS) AND LOADED ONTO AN UNSPECIFIED BAXTER PUMP, WITH NS USED AS THE CARRIER FLUID. DURVALUMAB WAS PREPARED AND SPIKED WITH UNSPECIFIED SECONDARY TUBING (SHORT SET) AND CONNECTED AT THE LUER LOCK (Y SITE) OF THE PRIMARY SET CLOSEST TO THE BAXTER PUMP. UPON INITIATION, THE PUMP IMMEDIATELY ALARMED FOR OCCLUSION, AND THE DRUG DID NOT INFUSE. DURVALUMAB REQUIRES A FILTER. THE TUBING WAS PLACED ON THREE (3) DIFFERENT BAXTER PUMPS, AND ALL THREE PUMPS GENERATED THE SAME OCCLUSION ALARM. THE SHORT SET WAS REMOVED FROM THE PRIMARY LINE. THE Y SITE NEAR THE PATIENT WAS FLUSHED AND DEMONSTRATED BLOOD RETURN. THE PATIENT HAD AN IMPLANTED PORT. THE TUBING WAS DISCONNECTED FROM THE PORT, WHICH WAS FLUSHED WITH A PRE FILLED NS SYRINGE WITHOUT RESISTANCE AND DEMONSTRATED GOOD BLOOD RETURN. A SECOND BAG OF DURVALUMAB WAS PREPARED WITH SHORT SET TUBING; HOWEVER, UPON RECONNECTION, THE PUMP AGAIN IMMEDIATELY ALARMED FOR OCCLUSION, AND THE DRUG DID NOT INFUSE. A THIRD BAG OF DURVALUMAB WITH SHORT SET TUBING WAS PREPARED, PRIMED WITH A FILTER, AND TESTED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035118 ↗
• MalfunctionApr 9, 2026

  NURSE WAS SETTING UP HAZARDOUS DRUG FLUSH LINE, WHILE ATTEMPTING TO PRIME TUBING THE TUBING FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829485 ↗
• MalfunctionApr 9, 2026

  PRIMARY TUBING SET ISSUE: DOWNSTREAM OCCLUSION ALARM IMMEDIATELY WHEN THE CHEMO WAS STARTED. THE Y-SITE OR MALE LUER LOCK ADAPTER VALVE WAS CLOGGED OR WOULD NOT INFUSE THROUGH. Y-SITE WHERE THE SHORT SET ATTACHES TO. THE PATIENT DID NOT REQUIRE PRE-MEDS BECAUSE HE TOOK DEXAMETHASONE AT HOME. DRUG WAS DOCETAXEL. NURSE CHANGED OUT THE WHOLE PRIMARY SET, CONNECTED THE SHORT SET TO THE NEW PRIMARY TUBING AND THE CHEMO WAS ABLE TO INFUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829319 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT SALINE SOLUTION LEAKED FROM THE ¿BLUE VENT VALVE¿ OF A CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823636 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET LEAKED. 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 24700976 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP SOLUTION SET LEAKED DURING SECONDARY INFUSION OF TAXOL. THE LOCATION OF THE LEAK WAS DESCRIBED AS "WHERE THE TWO PORTS CONNECT ON THE PRIMARY TUBING". THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. 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 24630750 ↗
• MalfunctionMar 18, 2026Protective Measures Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM - NON-DEHP SOLUTION SETS TRIGGERED AIR IN LINE AND UPSTREAM OCCLUSION ALARMS WITH THE SPECTRUM IQ PUMP; HOWEVER, THERE WAS NO REPORT OF OBSERVED AIR OR OCCLUSION, INDICATING THE ALARMS WERE FALSE. 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 24630718 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP SOLUTION SET LEAKED FROM THE BLUE VENT CAP. THIS OCCURRED DURING PRIMING WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629764 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. 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 24210508 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM - NON-DEHP SOLUTION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THE PROCESS STEP WAS NOT SPECIFIED, AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF THIS 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 24205306 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP 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 24193057 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP 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 24192383 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM - NON-DEHP SOLUTION SETS 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 24192351 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM - NON-DEHP 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 24192340 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING SALINE FROM THE PORT CLOSEST TO THE PATIENT. THE LEAK WAS OBSERVED WHILE THE PATIENT WAS CONNECTED FOR THERAPY. 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 24012646 ↗
• MalfunctionJul 10, 2025Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPIKE OF A CLEARLINK SYSTEM SOLUTION SET WAS NOT ATTACHED TO THE TUBING. THE SET WAS MISSING THE SPIKE PORT AND TIP PROTECTOR. 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 22469300 ↗

Recalls under the same FDA submission

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

• 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-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-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-1009-2025 · Dec 20, 2024 · Open, Classified
  Baxter Solution Set with Duo-Vent Spike, REF 2R8404
• Z-1291-2024 · Feb 8, 2024 · Open, Classified
  CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401