Edwards Lifesciences Vent Catheters — Class II medical device recall Z-0217-2015
Terminated recall by Edwards Lifesciences, LLC, reported 2014-11-26, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of
| Recall number | Z-0217-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2014-10-08 |
| Classified | 2014-11-14 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2016-12-15 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AU, BD, BR, CA, CL, CN, CO, HK, IN, JP, KR, LK, MX, MY, NL, SG, TW, VE |
| Quantity | 157,305 |
| Lot numbers | 59134589, 59138591, 59138592, 59148881, 59149673, 59149674, 59149675, 59151406, 59161706, 59163769, 59179981, 59182987, 59192002, 59192007, 59199148, 59202405, 59207364, 59211452, 59211456, 59216325, 59218844, 59222648, 59229509, 59229512, 59232182, 59235535, 59245610, 59245625, 59245648, 59245650, 59245652, 59258285, 59266772, 59271794, 59271795, 59283729, 59283731, 59287254, 59290438, 59295439 and 160 more |
| Model numbers | E060, E061, EM012, PE062 |
Product
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.
Reason for recall
Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.
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-0217-2015. 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.