FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
- Recall number
- Z-0800-2020
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
- Status
- Terminated
- Initiated
- 2019-11-27
- Posted
- not on file
- Terminated
- 2024-05-28
- Reason
- If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.
- Root cause
- Other
- Action
- On 11/27/19, Urgent Medical Device Safety Notices were mailed to customers (Attention: Risk Management Departments). Customers were informed the following: 1. Review the field safety notice to understand the potential hazard. 2. Meet and review with the appropriate clinical staff at your hospital. 3. Complete and return the acknowledgment form attached to this letter via fax (949-250-2525). 4. Distribute this notice within your organization or to any organization where the devices under the safety alert have been transferred. 5. Make the information available to personnel that may be using these devices as part of continuing communication and training. 6. Instructions for Use are being modified to add a contraindication for long term use (greater-than 6 hours, particularly during extracorporeal membrane oxygenation (ECMO) procedures. 7. Product return is not required. If you have additional questions, please contact customer service at 800-424-3278, Option 1, from 5:00 AM - 4:30 PM PST.
- Quantity
- 27168
- Distribution
- U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. O.U.S. (Foreign): Brazil, Colombia, Albania, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Namibia, Poland, Romania, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K981995"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28