FDA Device recall Z-0414-2024
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241c…
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241c… by Edwards Lifesciences, citing their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0414-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Edwards Lifesciences |
| Distribution | 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 |
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
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Identifiers
| code_info | PXAVMP:UDI: 00690103011494/Lot # 64817849; PXAVMP3: UDI:07460691950085/Lot # 64918575; PXVK0364:UDI:07460691954526/Lot…PXAVMP:UDI: 00690103011494/Lot # 64817849; PXAVMP3: UDI:07460691950085/Lot # 64918575; PXVK0364:UDI:07460691954526/Lot # 64858007; PXVK0853: UDI: 07460691957671/Lot # 65060361; PXVK0996:UDI: 07460691955431/Lot # 64858275; PXVMP2X21:UDI: 07460691950115/Lot # 64992080; PXVMP2X22: UDI: 00690103016765/Lot # 64891427; PXVMP3X32:UDI: 0690103016802/Lot # 65008748; PXVP0041: UDI: 00690103197983/Lot # 64835537; PXVP0550:UDI: 07460691949911/Lot # 64818013, 64858077, 64891424, 64918588, 64985484; PXVP1071: UDI: 07460691955462/Lot # 64807998, 64807999; PXVP1087: UDI: 07460691957886/Lot # 65035078, 65079515; PXVP2260: UDI: 07460691950108/Lot # 64858071, 64858103, 64891419, 64906892; PXVP2272:UDI: 07460691950184/Lot # 64752261, 64906891, 65138017; PXVP2284: UDI: 07460691950177/Lot # 64818005, 64818008, 64818011, 64891421, 64933492, 64933493, 64964755, 64964759, 64964760, 64964761, 64998878, 65060446; PXVP2284AT3: UDI: 07460691950436/Lot # 64722680, 64858285, 64951434, 64980108, 64992088; PXVP23X3:UD |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2024%22
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