Edwards Recalls QuickDraw Venous Cannula Due to Separation Complaints
Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate during withdrawal when using the percutaneous insertion method.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural failure of a medical device used in a high-risk surgical procedure (cardiopulmonary bypass), which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Edwards Lifesciences, LLC is recalling the QuickDraw Venous Cannula with Insertion Kit, models QD22 and QD25. The recall was initiated due to complaints that the cannula separated during withdrawal of the device when the percutaneous insertion method was used.
The affected products are used for patients undergoing cardiopulmonary bypass to drain non-oxygenated blood from the venae cavae or right atrium. The recall covers 22,616 units that were distributed worldwide, including the United States and Canada.
Healthcare providers should stop using the affected devices and contact Edwards Lifesciences for further instructions. Patients who have had the device implanted should contact their healthcare provider for evaluation.
The recalled product
- Product
- 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. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 22,616
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model QD22: Lot No. 59049758
- 59054488
- 59067502
- 59074170
- 59081626
- 59083736
- 59091652
- 59094887
- 59114755
- 59117451
- 59134508
- 59149651
- 59154310
- 59178579
- 59201243
- 59212118
- 59222657
- 59233636
- 59233637
- 59246684
Distribution
Distributed nationwide across the United States.
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