ThruPort Systems QuickDraw Venous Cannula with Insertion Kit QD22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103182699), received between Jan 27, 2020 and Jan 27, 2020 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K981995); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2020Gas/Air Leak

  PT REQUIRING VASOACTIVE SUPPORT WENT FROM UNIT TO CATH LAB FOR IABP PLACEMENT AND BACK TO CATH LAB FOR ECMO, UNTIL NURSE IDENTIFIED AIR IN ECMO CIRCUIT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9636575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981995. One submission often covers many models, so check the product and lot details in each record.

• Z-0800-2020 · Nov 27, 2019 · Terminated
  QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
• Z-1542-2013 · May 14, 2013 · Terminated
  QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.