EXPRESS 4050-100NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862115147), received between Sep 23, 2019 and Jun 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 13, 2023Open, Classified

   Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

   Z-0710-2024 · Root cause: Material/Component Contamination · FDA record ↗

2. Sep 18, 2023Open, Classified

   Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

   Z-0318-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

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

  MAUDE report 12091572 ↗
• MalfunctionSep 23, 2019Insufficient Flow or Under Infusion

  RECEIVED A REPORT THAT DEVICE WOULD NOT DRAIN CORRECTLY. UNIT WAS DISCARDED BECAUSE OF BLOOD BEING IN THE BOTTLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105555 ↗