ONE-LINK 7N8310Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00085412476728), received between Jan 19, 2018 and Feb 13, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K132734); 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.

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.

• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION, "CAUSING THE LIPID INFUSION TO NOT INFUSE AND THE IV TO BACK UP WITH BLOOD IN THE CANNULA". THE ISSUE OCCURRED DURING PATIENT INFUSION. THE TUBING WAS CHANGED 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 24339406 ↗
• MalfunctionNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP MICROBORE CATHETER EXTENSION SET CAME APART. THE ISSUE WAS FURTHER DESCRIBED THAT "THE EXTENSION PIECE HAD SPLIT AT THE EXTENSION WHERE IT CONNECTS TO PLASTIC." THE END CAPS WERE CHANGED AND "HEPARIN LOCKED." 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 23610525 ↗
• MalfunctionNov 18, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT TUBING OF A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET FELL APART FROM THE PATIENT'S PORT. THE ISSUE WAS FURTHER DESCRIBED AS, "THE PATIENT'S LINE DISCONNECTED FROM THE ONE-LINK CONNECTOR (CAP) ON THE PORT NEEDLE OF THE IV EXTENSION TUBING". THIS OCCURRED DURING PATIENT INFUSION WITH HEPARIN. THE SET WAS REPLACED WITH A NEW LINE AND FLUID ADMINISTRATION WAS RESTARTED. 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 23589190 ↗
• MalfunctionSep 5, 2025Backflow; Fluid/Blood Leak; Detachment of Device or Device Component; Backflow; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF ONE-LINK MICROBORE CATHETER EXTENSION SETS LEAKED FROM THE SCREW BY THE NEEDLE-FREE IV (INTRAVENOUS) CONNECTOR. THE LEAK IS FROM THE CONNECTION THAT IS UNBOUNDED. FLUID ALSO BACKS UP INTO THE EXTENSION TUBING AT TIMES. 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 22983534 ↗
• MalfunctionJun 1, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET LEAKED. FURTHERMORE, A HOLE WAS OBSERVED "THE MIDDLE OF THE TUBING" DURING AN UNSPECIFIED ANTIBIOTIC 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 14570876 ↗
• MalfunctionSep 2, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS HAD DISCONNECTION ISSUES WITH CONTRAST LEAKING. THE DISCONNECTION WAS COMING FROM THE PART WHERE IT SCREWED INTO THE INTRAVENOUS CATHETER. THE CONTRAST WOULD LEAK OUT MID INJECTION, AS A RESULT THE PATIENT¿S DID NOT RECEIVE ENOUGH CONTRAST AND THE CT RESULTS WOULD BE UNDIAGNOSTIC; OR THE PATIENT WOULD HAVE TO RECEIVE EXTRA RADIATION TO COMPENSATE FOR THE LACK OF ENOUGH CONTRAST. 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 12416550 ↗
• MalfunctionSep 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS HAD HEMOLYZING ISSUES. IT WAS FURTHER REPORTED THAT THE PATIENT¿S BLOOD WOULD HEMOLYZE IMMEDIATELY AFTER STARTING THE INTRAVENOUS LINES AND DRAWING THE BLOOD INTO THE TUBING. THIS ISSUE OCCURRED DURING USE AT THE EMERGENCY 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 12416518 ↗
• MalfunctionMay 19, 2021No Flow; No Flow

  IT WAS REPORTED TEN (10) ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS WOULD NOT FLOW. IT WAS FURTHER REPORTED, "WHEN THE NURSE CONNECTED THE IV CONNECTOR THE ARE NOT ABLE TO DRAW BLOOD AS THE TUBING HAS NO SUCTION TO DRAW UP THE BLOOD AND END UP USING A SYRINGE TO DRAW UP THE BLOOD". THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850750 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility

  16 CASES OF THE BAXTER ONE-LINK AND SMITHS MEDICAL JELCO IV CATHETER SEPARATING DURING POWER INJECTION REQUIRED FOR CT SCAN. THIS HAS LEAD TO THE PATIENTS BEING REQUIRED TO RECEIVE REINJECTION AND REIMAGING. APPEARS TO BE SECONDARY TO THE TWO DEVICES NOT BEING COMPATIBLE WITH ONE ANOTHER. MANUFACTURER RESPONSE FOR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS, JELCO (PER SITE REPORTER). INSERVICES HAVE BEEN PROVIDED TO STAFF BY BAXTER AND SMITH'S MEDICAL REGARDING THE USE OF THESE TWO DEVICES TOGETHER WITH LESS THAN OPTIMAL RESULTS. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, ONE-LINK (PER SITE REPORTER). BOTH BAXTER AND SMITH'S MEDICAL HAVE PROVIDED SEVERAL INSERVICES IN AN ATTEMPT TO ADDRESS ANY EDUCATION ISSUES WHICH MIGHT BE AT HAND. INSERVICES HAVE NOT BEEN AS EFFECTIVE AS PLANNED AND THESE TWO DEVICES HAVE CONTINUED TO PRODUCE ISSUES DURING POWER INJECTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202758 ↗
• MalfunctionJul 10, 2019Device Damaged Prior to Use

  EXTENSION CATHETER FOUND TO BE IN TWO PIECES PRIOR TO PACKAGING BEING OPENED. PRODUCT WAS DAMAGED IN THE MIDDLE OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775585 ↗
• MalfunctionApr 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET DISCONNECTED. THE CATHETER AND TUBING CAME APART DURING IV CONTRAST DYE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446801 ↗
• MalfunctionApr 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A ONE-LINK CATHETER EXTENSION SET DISCONNECTED. THE CATHETER AND TUBING CAME APART DURING IV CONTRAST DYE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441649 ↗
• MalfunctionApr 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A ONE-LINK CATHETER EXTENSION SET DISCONNECTED. THE CATHETER AND TUBING CAME APART DURING IV CONTRAST DYE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441389 ↗
• MalfunctionApr 18, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET EXPERIENCED A CONNECTION ISSUE WHICH RESULTED IN A LEAK. THE CATHETER AND TUBING BECAME DISCONNECTED DURING INTRAVENOUS INFILTRATION OF CONTRAST DYE TO THE PATIENT. 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 7439853 ↗
• MalfunctionApr 18, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET EXPERIENCED A CONNECTION ISSUE WHICH RESULTED IN A LEAK. THE CATHETER AND TUBING BECAME DISCONNECTED DURING INTRAVENOUS INFILTRATION OF CONTRAST DYE TO THE PATIENT. 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 7439851 ↗
• MalfunctionApr 18, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR AND TUBING CAME APART DURING INTRAVENOUS CONTRAST DYE INFILTRATION. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439599 ↗
• MalfunctionMar 22, 2018Detachment Of Device Component

  IV CATHETER AND TUBING CAME APART DURING IV CONTRAST DYE INFILTRATION (SMITHS MEDICAL IV CATHETER AND BAXTER ONE-LINK EXTENSION SET).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361408 ↗
• MalfunctionJan 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT¿S ONE-LINK EXTENSION SET LEAKED. 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 7206394 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132734. One submission often covers many models, so check the product and lot details in each record.

• Z-1102-2021 · Dec 21, 2020 · Terminated
  Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended
• Z-0132-2016 · May 21, 2015 · Terminated
  ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT