TruWave with Vamp System Pressure monitoring set — Class II medical device recall Z-0414-2024
Ongoing recall by Edwards Lifesciences, LLC, reported 2023-12-06, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra
| Recall number | Z-0414-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2023-10-04 |
| Classified | 2023-11-29 |
| Reported by FDA | 2023-12-06 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DK, EC, ES, FR, GB, GR, GT, HK, ID, IE, IL, IT, JP, KR, MY, NL, NO, NZ, PA, PL, PT, SA, SE, SG, SI, SK, VN |
| Quantity | 168,014 units |
| UPC / GTIN / UDI-DI | 00690103011494, 00690103016765, 00690103016802, 00690103197945, 00690103197983, 00690103200386, 00690103210798, 07460691931572, 07460691947290, 07460691947566, 07460691947627, 07460691948259, 07460691949188, 07460691949553, 07460691949911, 07460691950085, 07460691950092, 07460691950108, 07460691950115, 07460691950177, 07460691950184, 07460691950436, 07460691950443, 07460691950467, 07460691954526 and 10 more |
| Lot numbers | 64526411, 64629075, 64695848, 64722680, 64752261, 64779279, 64779289, 64793360, 64807926, 64807977, 64807998, 64807999, 64817809, 64817812, 64817834, 64817849, 64817936, 64818005, 64818008, 64818011, 64818013, 64835537, 64835538, 64835567, 64835568, 64835579, 64858007, 64858071, 64858072, 64858075, 64858077, 64858103, 64858230, 64858275, 64858285, 64858290, 64891376, 64891383, 64891419, 64891421 and 95 more |
Product
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm); PXVMP3X32: x3 (3cc)/VAMP 75in (190cm); PXVP0041: (3cc)/VAMP Plus 96in (244cm); PXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm); PXVP1071: x3 (3cc)/VAMP Plus 87in (221cm); PXVP1087: x4(3cc)/VAMP Plus; PXVP2260: (3cc)/VAMP Plus 60in (150cm); PXVP2272: (3cc)/VAMP Plus 72in (180cm); PXVP2284: (3cc)/VAMP Plus 84in (210cm); PXVP2284AT3: (3cc)/VAMP Plus 84in (210cm); PXVP23X3: x3: (3cc)/VAMP Plus; PXVP23X3AT3: x3 (3cc)/VAMP Plus; PXVP2X2AT3: x2 (3cc)/VAMP Plus; PXVPL0111: (3cc)/VAMP Plus 84in (213cm); PXVMP160: 3cc/VAMP 60 in (150cm); PXVMP172: 3cc/VAMP 72in)180cm); PXVMP184:3cc/VAMP 84in (210cm); PXVMP260:3cc/VAMP 60in (150cm); PXVFL10017: (3cc)/VAMP Flex 83in (210cm); PXVP0034: (3cc)/VAMP Plus 87in (220cm); T001691A: (3cc)/VAMP Plus; T001691M: (3cc)/VAMP Plus (215cm); T001744M:(3cc)/VAMP 93in (236 cm); T100671M: x3(3cc)/VAMP Plus (215cm); T001760A :x2(3cc)/VAMP Plus; T001765A: (3cc)/60in (150cm); T005021M: (3cc)/VAMP Flex (195cm); T005089M: x2 (3cc)/VAMP Flex (195 cm) ; T005091M: x3(3cc)/VAMP Flex (195cm); T434501B: x2(3cc)/VAMP 88in (225cm); T440B26B: x2 (3cc)/VAMP 88in (225cm); T450545A: x3 (3cc)/VAMP 75in (190cm); T460241A: (3cc)/VAMP Plus 69in (175cm); T530219D: x2 (3cc)/VAMP Plus 65in (165cm)
Reason for recall
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
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-0414-2024. 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.