EXTENSION SET 2H5660Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00085412065328), received between Feb 21, 2018 and May 29, 2026 — classified as 3 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 reports).

2 other recalls cover devices cleared under the same FDA submission (K153158); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP EXTENSION SET LEAKED DURING A TOTAL PARENTERAL NUTRITION (TPN) 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 25338540 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE FILTER OF A NON-DEHP EXTENSION SET WAS BROKEN. THE ISSUE WAS NOTICED WHILE THE DEVICE WAS TAKEN OUT OF THE PACKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622235 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT THE FILTER ON A NON-DEHP EXTENSION SET WAS BROKEN. WHILE REMOVING THE DEVICE FROM THE PACKAGING, PRIOR TO PATIENT USE, IT WAS OBSERVED THAT THERE WAS A BREAK IN THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611751 ↗
• MalfunctionOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTENSION SET LEAKED FROM THE FILTER. THIS WAS OBSERVED DURING USE. THE DEVICE CONTAINED 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 23397482 ↗
• MalfunctionOct 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET WAS LEAKING FROM THE FILTER (PATIENT SIDE). THE LEAK WAS OBSERVED DURING PATIENT INFUSION OF 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 23203422 ↗
• InjuryAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PARTICULATE WAS OBSERVED IN A NON-DEHP EXTENSION SET. TWENTY-ONE AND A HALF HOURS INTO A 24-HOUR CHEMOTHERAPY INFUSION (ETOPOSIDE, DOXORUBICIN, VINCRISTINE), THE PATIENT NOTED ¿WHITE PARTICLES INSIDE THE ROUND PLASTIC¿; WHICH APPEARED TO BE ¿CREAKING AND LITTLE PARTICLES VISIBLE INSIDE ROUND PLASTIC HOUSING.¿ THE INFUSION WAS STOPPED, AND THE NURSE OBTAINED A NEW FILTER, PRIMED IT, AND REPLACED THE CURRENT FILTER. APPROXIMATELY ONE HOUR LATER, THE PATIENT OBSERVED ¿MORE PARTICLES IN THE FILTER HOUSING AND THEY WERE TRAVELING UP THE LINE, TOWARDS THE PUMP.¿ THE INFUSION WAS STOPPED. THE NURSE NOTED THERE WAS ONLY APPROXIMATELY 5ML IN THE BAG, ALONG WITH THE SOLUTION IN THE DRIP CHAMBER AND TUBING LINE. THE INFUSION WAS DISCONTINUED. THE PATIENT SUSTAINED AN UNKNOWN SERIOUS INJURY REQUIRING THE TUBING TO BE SWAPPED AND REPRIMED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 22844095 ↗
• InjuryAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PARTICULATE WAS OBSERVED IN A NON-DEHP EXTENSION SET. TWENTY-ONE AND A HALF HOURS INTO A 24-HOUR CHEMOTHERAPY INFUSION (ETOPOSIDE, DOXORUBICIN, VINCRISTINE), THE PATIENT NOTED ¿WHITE PARTICLES INSIDE THE ROUND PLASTIC¿; WHICH APPEARED TO BE ¿CREAKING AND LITTLE PARTICLES VISIBLE INSIDE ROUND PLASTIC HOUSING.¿ THE INFUSION WAS STOPPED, AND THE NURSE OBTAINED A NEW FILTER, PRIMED IT, AND REPLACED THE CURRENT FILTER. APPROXIMATELY ONE HOUR LATER, THE PATIENT OBSERVED ¿MORE PARTICLES IN THE FILTER HOUSING AND THEY WERE TRAVELING UP THE LINE, TOWARDS THE PUMP.¿ THE INFUSION WAS STOPPED. THE NURSE NOTED THERE WAS ONLY APPROXIMATELY 5ML IN THE BAG, ALONG WITH THE SOLUTION IN THE DRIP CHAMBER AND TUBING LINE. THE INFUSION WAS DISCONTINUED. THE PATIENT SUSTAINED AN UNKNOWN SERIOUS INJURY REQUIRING THE TUBING TO BE SWAPPED AND REPRIMED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 22844083 ↗
• MalfunctionJun 3, 2025Backflow; Air/Gas in Device; Backflow; Air/Gas in Device

  IT WAS REPORTED THAT BACKFLOW AND AIR WERE OBSERVED DURING USE OF AT LEAST ONE (1) NON-DEHP EXTENSION SET. THE PROCESS STEP WAS NOT SPECIFIED. A NON-DEHP SECONDARY MEDICATION SET WAS CONNECTED TO A 500 ML BAG ETOPOSIDE PLUS THE NON-DEHP EXTENSION SET THAT WAS "Y'D" (CONNECTED) TO A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET VIA A SIGMA SPECTRUM INFUSION PUMP. 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 22137301 ↗
• MalfunctionJun 3, 2025Backflow; Air/Gas in Device; Backflow; Air/Gas in Device

  IT WAS REPORTED THAT BACKFLOW AND AIR WERE OBSERVED DURING USE OF AT LEAST ONE (1) NON-DEHP EXTENSION SET. THE PROCESS STEP WAS NOT SPECIFIED. A NON-DEHP SECONDARY MEDICATION SET WAS CONNECTED TO A 500 ML BAG ETOPOSIDE PLUS THE NON-DEHP EXTENSION SET THAT WAS "Y'D" (CONNECTED) TO A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET VIA A SIGMA SPECTRUM INFUSION PUMP. 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 22136574 ↗
• MalfunctionMay 29, 2025Disconnection; Fluid/Blood Leak; Air/Gas in Device; Disconnection; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP EXTENSION SETS DISCONNECTED FROM AT LEAST ONE (1) PATIENT. THE EVENT WAS FURTHER DESCRIBED AS "THE FILTER HAS EVACUATED SPONTANEOUSLY". THIS OCCURRED WHILE THE SETS WERE BEING USED WITH A NON-BAXTER PRIMARY PUMP SET AND A NON-BAXTER INFUSION PUMP. THIS EVENT RESULTED IN FLUID/MEDICATIONS SPILLING ONTO THE FLOOR AND AIR IN THE INTRAVENOUS (IV) TUBING. THIS OCCURRED DURING PATIENT INFUSION WITH PROPOFOL. THE MEDICATION WAS DISCONNECTED FROM THE PATIENT AFTER THE INFUSION WAS PAUSED. 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 22109795 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT FORTY-EIGHT (48) NON-DEHP EXTENSION SETS HAD A SMALL PINHOLE (NOT VISIBLE) IN THE TUBING RESULTING IN A LEAK. THIS WAS OBSERVED BEFORE PATIENT USE. THE SETS WERE IN USE WITH UNSPECIFIED NON-BAXTER PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074161 ↗
• MalfunctionAug 12, 2024Backflow; Fluid/Blood Leak; Air/Gas in Device; Backflow; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT BLOOD BACKED UP INTO A NON-DEHP EXTENSION SET WHICH WAS ALSO LEAKING AIR INTO THE FILTER AND LEAKING FLUID FROM AN UNSPECIFIED LOCATION. THIS EVENT WAS OBSERVED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19960281 ↗
• MalfunctionJun 14, 2024Backflow; Fluid/Blood Leak; Air/Gas in Device; Backflow; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE BLOOD PULLED BACK FROM A CENTRAL VENOUS CATHETER (CVC) DURING USE OF A NON-DEHP EXTENSION SET AND FLUID LEAKED. THIS OCCURRED DURING PATIENT USE. THE EVENT WAS FURTHER DESCRIBED AS "AIR PASSING AND LEAKING FLUID". 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 19543310 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THAT THE CONNECTION BROKE ON AN EXTENSION SET WITH A 0.2 MICRON FILTER. THE CONNECTION BROKE WHILE ATTEMPTING TO SEPARATE THE FILTER FROM THE LINE TO ADD A SPIROS. 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 19191492 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER OF A NON-DEHP I.V. EXTENSION SET WAS LEAKING DURING 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 19061795 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET LEAKED FROM THE FILTER DURING AN UNSPECIFIED 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 19042072 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED 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 19012398 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP MICRON EXTENSION SET LEAKED FROM THE TOP OF THE FILTER. THIS WAS OBSERVED DURING PATIENT INFUSION WITH CHEMOTHERAPY DRUG. NEW TUBING WAS USED AND PRIMED TO CONTINUE TREATMENT. 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 18881789 ↗
• MalfunctionFeb 27, 2024No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP EXTENSION SETS HAD EITHER NO FLOW OR REDUCED FLOW THROUGH THE FILTER WITH A VARIETY OF MEDICATIONS. 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 18793786 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET SEPARATED WHICH RESULTED IN A LEAK. THE ISSUE OCCURRED DURING USE. BLOOD BACKED UP INTO THE PATIENT'S PORT AND POOLED ONTO THE FLOOR. UNSPECIFIED MEDICATION LEAKED ONTO THE PATIENT AND THE FLOOR. THE PATIENT CLEANED UP AND CHANGED THEIR CLOTHES. 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 17086113 ↗
• MalfunctionMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET LEAKED. THE ISSUE OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973593 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET WAS LEAKING FROM THE FILTER. THIS WAS OBSERVED AFTER 5 HOURS OF RUNNING PACLITAXEL THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438540 ↗
• MalfunctionAug 30, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP EXTENSION SET LEAKED FROM THE CONNECTION SITE. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿DISCONNECTED TUBING DISCOVERING MALE END OF TUBING WAS BROKEN OFF¿. THE ISSUE 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 15324355 ↗
• MalfunctionJul 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF A NON-DEHP EXTENSION SETS WERE LEAKING FROM THE FILTER. THE ISSUE 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 15052921 ↗
• MalfunctionJul 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF A NON-DEHP EXTENSION SETS WERE LEAKING FROM THE FILTER. THE ISSUE 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 15052906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.

• Z-0196-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
• Z-0195-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8