Channel Drain V072230Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741051616), received between May 19, 2017 and Apr 27, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT WHEN PLACING THE SILICONE CHANNEL DRAIN TO SUCTION, IT WAS COLLAPSING AND PREVENTING BLOOD FROM THE CHEST TO PASS THROUGH. IT WAS STATED THAT THE TUBE PRESENTED TO BE MORE RIGID THAN USUAL. THE CUSTOMER CURRENTLY HAD TWO CASES AT THE CSC.

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

  MAUDE report 14218822 ↗
• MalfunctionAug 14, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE DRAIN APPEARED TO BE THE INCORRECT SIZE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6793512 ↗
• MalfunctionJul 31, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE PACKAGE SHOULD HAVE CONTAINED A 19FR. CATHETER; HOWEVER, A 24FR. CATHETER WAS INSIDE OF THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6755289 ↗
• MalfunctionJun 29, 2017Fitting Problem

  IT WAS REPORTED THAT THE SIZE OF THE CHANNEL DRAIN WAS LARGER THAN DEVICES PREVIOUSLY USED (B)(4), AND WOULD NOT FIT ON THE BULB. THE USER STATED THERE WAS A VISIBLE DIFFERENCE IN DIAMETER WHEN THE DRAINS WERE NEXT TO EACH OTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6679850 ↗
• MalfunctionJun 8, 2017Incorrect Measurement

  IT WAS REPORTED THAT THE PACKAGING STATED THAT THE ITEM WAS 24 FR., BUT THE DRAIN INSIDE THE PACKAGING WAS A 19 FR..

  Patient problems: No Patient Involvement

  MAUDE report 6622890 ↗
• MalfunctionMay 25, 2017Inadequate Instructions for Healthcare Professional; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593046 ↗
• MalfunctionMay 25, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593025 ↗
• MalfunctionMay 25, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593020 ↗
• MalfunctionMay 25, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593004 ↗
• MalfunctionMay 25, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6592991 ↗
• MalfunctionMay 25, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6592973 ↗
• MalfunctionMay 25, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6592972 ↗
• MalfunctionMay 25, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6592971 ↗
• MalfunctionMay 25, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE PACKAGING WAS LABELED AS A 19FR. DEVICE; HOWEVER, THE DEVICE INSIDE WAS ALLEGEDLY LARGER THAN 19FR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6592970 ↗
• MalfunctionMay 19, 2017Incorrect Measurement

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS NOT SIZE 19 FR LIKE IT SHOULD BE. THE COMPLAINANT STATED THAT THE CHANNEL DRAIN APPEARED TO BE LARGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578724 ↗