Cook G02278Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002022782), received between May 21, 2018 and Sep 25, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 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. Aug 16, 2022Open, Classified

   Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

   Z-1844-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Contaminated During Manufacture or Shipping

  It was reported that a hair like fiber was seen within the sealed sterile packaging of a Drainage Bag Connector Connecting Tube. A customer provided photo shows a small hair like fiber within a sealed package.The device did not make patient contact. No adverse effects or additional procedures were reported for this incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897590 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681995 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IN ADDITIONAL INFORMATION RECEIVED ON 20MAR2026, IT WAS REPORTED THAT THE DRAINS WERE NOT BEING REMOVED WHEN THE DETACHMENT WAS NOTED; HOWEVER, THE DRAINS WERE REMOVED AS A RESULT OF THE HUB SEPARATION. THIS OCCURRED FOR 2 SEPARATE LOTS: 16627006 AND 16623474. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS HUB DETACHMENT FROM THE CATHETER. THIS REPORT CAPTURES HUB SEPARATION OCCURRING FOR LOT 16627006. THE ADDITIONAL COMPLAINT LOT 16623474 IS REFERENCED IN A REPORT WITH PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840583 ↗
• MalfunctionDec 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IN ADDITIONAL INFORMATION RECEIVED ON 27JAN2026, IT WAS REPORTED THAT THE FUNCTIONALITY OF THE DEVICE WAS NOT TESTED PRIOR TO NOTICING THE DAMAGE, AS THE DARK SPOT WAS CONSIDERED TO BE A POTENTIAL CONTAMINATE. AS A RESULT, THE DEVICE WAS NOT PREPPED/USED. IT WAS CONFIRMED THAT THE DEVICE WAS STORED ACCORDING TO THE CONDITIONS NOTED ON THE LABEL. IT IS NOT BELIEVED THAT ANY HANDLING CONDITIONS OF THE FACILITY COULD HAVE CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840469 ↗
• MalfunctionJan 2, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426467 ↗
• MalfunctionAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PER ADDITIONAL INFORMATION, NEW VINYL CONNECTING TUBE WAS USED AFTER THE FAILURE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442850 ↗
• InjuryMay 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOUR DRAINAGE BAG CONNECTOR CONNECTING TUBES WERE ORDERED BUT NOT RECEIVED. THIS MEANT THE PATIENT SCHEDULED TO HAVE TWO CHEST TUBES PLACED ON (B)(6) 2018 HAD TO RESCHEDULE OR GO TO ANOTHER FACILITY. THIS INCIDENT IS REPORTED AS AN ADVERSE EVENT AS PATIENT CARE WAS ALLEGEDLY POSTPONED.

  Patient problems: No Patient Involvement

  MAUDE report 7529379 ↗