QuickDraw Venous Cannula with Insertion Kit — Class II medical device recall Z-1542-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-06-19, distributed nationwide. Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of
| Recall number | Z-1542-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-05-14 |
| Classified | 2013-06-12 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2014-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 22,616 |
| Lot numbers | 59046082, 59046847, 59049758, 59052393, 59052395, 59054488, 59056270, 59059029, 59060798, 59062681, 59067502, 59069772, 59073141, 59074170, 59077234, 59079573, 59081626, 59083736, 59085168, 59085169, 59091652, 59094887, 59097289, 59101637, 59106005, 59110720, 59114755, 59117451, 59122491, 59126281, 59131923, 59134508, 59140133, 59142266, 59143453, 59145027, 59149651, 59154310, 59158524, 59158579 and 65 more |
| Model numbers | QD22, QD25 |
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 shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed, peel-type pouch.
Reason for recall
Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1542-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.