NA 6431233BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07332414004699), received between Nov 23, 2021 and May 20, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ACCESSORY Y CONNECTOR WAS OBSERVED TO BE CRACKED AT THE ARTERIAL BRANCH CONNECTION AND LEAKED BLOOD DURING THERAPY. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052000 ↗
• MalfunctionMar 28, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING DIALYSIS TREATMENT USING A Y CONNECTOR LINE ACCESSORY, ¿SIGNALING OF AN AIR INGRESS WAS IDENTIFIED. IT WAS REPORTED THAT THE LINE WAS CLAMPED, AND THE Y CONNECTOR WAS REPLACED PRIOR TO ANY AIR BUBBLES ENTERING THE PATIENT. 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 21724592 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED IN THE AREA OF THE ARTERIAL LIMB OF AY CONNECTOR S660 LINE ACCESSORY DURING THERAPY. THE VOLUME OF BLOOD LOSS WAS APPROXIMATELY 100ML. THEY CONNECTOR WAS CHANGED TO CONTINUE TREATMENT. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED "AIR INSUFFLATION", HOWEVER THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635133 ↗
• MalfunctionJan 31, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT A Y CONNECTOR S 660 LINE ACCESSORY WAS DISCONNECTED FROM THE PATIENT CATHETER AND LEAKED BLOOD DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287502 ↗
• MalfunctionJan 12, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE VENOUS LINE OF A S 660 ACCESSORY Y CONNECTOR. AIR ENTERED THE LINE AT THE ARTERIAL LINE CONNECTION POINT AND RESULTED IN THE LEAK. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134136 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A Y CONNECTOR S 660 LINE ACCESSORY DURING HEMODIALYSIS THERAPY. A MICROFOAM ALARM WAS TRIGGERED AFTER (2) HOURS AND (5) MINUTES OF TREATMENT. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THE CONNECTOR WAS REPLACED TO CONTINUE THERAPY. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127742 ↗
• InjuryDec 20, 2023Break; Air/Gas in Device; Break; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A FILTER SET AND A Y CONNECTOR. IT WAS FURTHER REPORTED THAT WHILE ATTEMPTING TO RETURN BLOOD AND START A NORMAL SALINE RECIRCULATION, THE DEVICE ¿MALFUNCTIONED¿ AND AS A RESULT, THE EXTRACORPOREAL (EC) BLOOD WAS NOT RETURNED. ACCORDING TO THE REPORTER, A SECOND Y CONNECTOR WAS OBTAINED, HOWEVER, IT WAS NOTICED TO BE BROKEN AT THE CONNECTION HUB. A THIRD Y CONNECTOR WAS REPORTED TO BE NEEDED, HOWEVER, TOO MUCH AIR HAD ENTERED THE CIRCUIT DUE TO THE BROKEN Y-CONNECTOR, AND TREATMENT WAS TERMINATED WITHOUT THE EC BLOOD RETURNING TO THE PATIENT. THE PATIENT RECEIVED A BLOOD TRANSFUSION LATER IN THE SHIFT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18369771 ↗
• MalfunctionNov 23, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THREE (3) ACCESSORIES Y CONNECTOR S 660 C DID NOT CONNECT PROPERLY ON THE DIALYSIS LINE. NO LEAKS WERE REPORTED TO HAVE OCCURRED. 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 12863366 ↗