MPS 3 ND Delivery Set w/AA w/305cm Line (16C) 5ND3102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00634624530348), received between Apr 4, 2022 and Dec 4, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionDec 4, 2025Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  THE REPORT STATES A LEAK APPEARED; BLOOD WAS ONLY APPEARING TO LEAK. MEDICATION WAS ADMINISTERED, THERE WERE NO DELAYS IN THE PROCEDURE, THE LEAK CONTINUED THROUGHOUT THE CASES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716742 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORT RECEIVED STATES THAT A NEEDLE SIZE HOLE WAS DISCOVERED IN THE CASSETTE AFTER THE CUSTOMER STARTED USING THE DEVICE. BLOOD WAS LEAKING FROM CONSOLE DOOR. THE PATIENT HAD SOME BLOOD LOSS. CARDIOPLEDGIA WAS ADMINISTERED AND THE DISPOSABLE WAS REPLACED ON BYPASS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22447972 ↗
• MalfunctionFeb 21, 2025Particulates; Particulates

  THE REPORT RECEIVED STATES THAT A STRANGE FLAW WAS SEEN AT THE INLET TO ADDITIVES LL AT THE HEAT EXCHANGER WHEN SETTING UP THE DEVICE FOR A CASE. THE DEVICE WAS REPLACED AND WAS NOT USED FOR THE CASE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432814 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL OF AN ALLEGEDLY LEAKING MPS DELIVERY SET. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442565 ↗
• MalfunctionJul 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL OF AN MPS DELIVERY SET ((B)(4)) THAT WAS ALLEGEDLY LEAKING DURING A CASE. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135985 ↗
• MalfunctionMay 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) HOSPITAL OF AN ALLEGED DISPOSABLE LEAK DURING A CASE. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14553150 ↗
• MalfunctionApr 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED BY QUEST MEDICAL FROM COX HEALTH STATING THAT, DURING A PROCEDURE, THE MPS 3 ND KIT WAS ALLEGEDLY LEAKING. IT WAS FURTHER STATED THAT THE LEAK WAS ALLEGEDLY COMING FROM THE PUMP CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115695 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED FROM A CUSTOMER STATING THAT THERE WAS OBSERVED TO BE AN ALLEGED LEAK IN THE MPS SET DURING SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002171 ↗