EZ Glide Aortic Cannula — Class II medical device recall Z-0420-2020
Terminated recall by Edwards Lifesciences, LLC, reported 2019-11-27, distributed nationwide. Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circu
| Recall number | Z-0420-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2019-10-22 |
| Classified | 2019-11-18 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2022-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CL, CN, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HU, IE, IN, IS, IT, JP, MX, MY, NL, NO, PL, RO, SE, SG, SK, TH, TR, ZA |
| Quantity | 62,431 units |
| UPC / GTIN / UDI-DI | 00690103172096, 00690103172102, 00690103172119, 00690103172126, 00690103174182, 00690103174199, 00690103175066, 00690103175073, 00690103175080, 00690103175097, 00690103714401, 00690103714418 |
| Lot numbers | 203876, 205724, 205775, 205868, 205920, 205921, 205922, 206369, 206372, 206373, 206374, 206768, 206769, 206770, 206771, 206772, 206773, 206774, 206775, 206776, 206777, 206778, 207319, 207320, 207321, 207322, 207323, 207324, 207636, 207638, 207654, 207655, 208823, 208893, 208894, 209901, 209904, 210110, 210111, 212032 and 71 more |
Product
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.
Reason for recall
Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.
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-0420-2020. 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.