EXTENSION SETRecalls & reported problems across all models

We found 5 models of EXTENSION SET by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2018 and Sep 11, 2026 — classified as 3 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (49 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EXTENSION SET problems

EXTENSION SET models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EXTENSION SET 2H5660

  Set, administration, intravascular
  46 reports
• EXTENSION SET 2N3382

  Set, administration, intravascular
  17 reports
• EXTENSION SET 2N3354

  Set, administration, intravascular
  10 reports
• EXTENSION SET 2N3357

  Set, administration, intravascular
  4 reports
• EXTENSION SET 2N3359

  Set, administration, intravascular
  1 report

Recent EXTENSION SET adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741193 ↗
• MalfunctionSep 9, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699090 ↗
• MalfunctionAug 17, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288000 ↗
• MalfunctionAug 17, 2026Air/Gas in Device

  It was reported that a Micro-Volume Extension Set with 0.2 Micrometer Filter exhibited air in the line. The issue was identified during a Normal Saline (NS) flush. The treatment was being administered through a peripheral intravenous (PIV) catheter when the infusion pump alarmed for a downstream occlusion. The line and IV site were assessed, and no occlusion was identified. Further evaluation of the medication line filter revealed the presence of air within the filter. The flush was stopped and the medication line was subsequently discarded. 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 50280757 ↗
• MalfunctionAug 14, 2026Backflow; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246511 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS WITH 0.2 M FILTER WERE LEAKING FROM THE AIR VENTING MECHANISM. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. IT WAS STATED THAT USERS MANUALLY PRIME THE LINES, OCCASIONALLY USING SYRINGES SMALLER THAN 10ML. 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 25417142 ↗
• MalfunctionJun 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) MICRO-VOLUME EXTENSION SETS WITH 0.2 MICRON FILTER LEAKED FROM THE AIR VENTING MECHANISM. THIS OCCURRED 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 25385492 ↗
• 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 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET WITH 0.2 M FILTER LEAKED FROM THE AIR VENTING MECHANISM. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. IT WAS STATED THAT USERS MANUALLY PRIME THE LINES, OCCASIONALLY USING SYRINGES SMALLER THAN 10ML. THERE WERE NO REPORTS 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 25338353 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET WITH 0.2 MICROMETER FILTER LEAKED FLUIDS FROM AN UNSPECIFIED LOCATION. THIS WAS DURING PATIENT INFUSION VIA AN ARTERIAL LINE. THE SYRINGE PUMP WAS PROGRAMMED TO DELIVER AT A RATE OF 0.5 ML/HOUR. 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 25334204 ↗
• MalfunctionMay 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THE EVENT OCCURRED AT THE NICU DEPARTMENT. 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 25305821 ↗
• MalfunctionMay 18, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS OBSERVED IN A MICRO-VOLUME EXTENSION SET CONNECTED TO A BAXTER LIPID FILTER. THE ISSUE WAS IDENTIFIED WHILE THE REGISTERED NURSE WAS PRIMING THE LINE ON THE INFUSION PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210851 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE CONNECTION WITH A BAXTER LIPID FILTER. PATIENT WAS CONNECTED DURING 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 25210588 ↗
• MalfunctionJan 8, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET HAD A CRACK NEAR THE CONNECTION TO A NON-BAXTER NEEDLELESS CONNECTOR RESULTING IN A MEDICATION LEAK. THE ISSUE WAS FURTHER DESCRIBED AS "THE SYRINGE LINE ON THE RED LUMEN WAS FOUND TO BE CRACKED AND LEAKING". THIS WAS OBSERVED WHEN FLUSHING THE SET. THE SYRINGE LINE (SET) 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 24011144 ↗
• 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 ↗

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