CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report
TruWave with Vamp System Pressure monitoring set recalled
Edwards Lifesciences is recalling TruWave with Vamp System Pressure monitoring set, distributed in 43 states. The recall was initiated on 4 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0414-2024
- FDA event ID
- 93279
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2023
- FDA classified
- 29 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 4 Oct 2023 | Recall initiated by company | |
| 29 Nov 2023 | Classified by FDA | +56 days |
| 6 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Product as listed by the FDA
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)
Where it was distributed
US: 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 OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Is TruWave with Vamp System Pressure monitoring set recalled?
Yes. Edwards Lifesciences recalled TruWave with Vamp System Pressure monitoring set on 4 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0414-2024.
Why was it recalled?
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Which lots are affected?
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:UDI: 07460691950092/Lot # 64998879, 65060444; PXVP23X3AT3: UDI: 07460691950443/Lot # 64695848, 64779289, 64858072, 64858290, 64992092,65060447; PXVP2X2AT3: UDI:07460691950467/Lot # 64858075; PXVPL0111: UDI: 00690103200386/Lot # 64933462; PXVMP160: UDI:/Lot # 64779279, 64918578, 64933556, 64933559; PXVMP172: UDI:/Lot # 64835579; PXVMP184:UDI:/Lot # 64949045, 64983460, 65042811; PXVMP260:UDI:/Lot # 64629075, 64964750, 64980101; PXVFL10017:UDI:00690103210798/Lot # 64923241; PXVP0034:UDI:00690103197945/Lot # 64835538, 65019842; T001691A:UDI: 07460691947627/Lot # 64793360 64807977 64817834 64835567 64835568 65008739 65019862 65035054 65048943; T001744M:UDI: 07460691959507/Lot # 64526411, 64891383; T100671M:UDI: 07460691959491/Lot # 64912244; T001760A: UDI:07460691947566/ Lot # 65008764, 65019890, 65067580; T001765A: UDI:07460691947290/ Lot # 64891376, 64906871, 64980035, 64983290, 65035029; T005021M:UDI:07460691959538/ Lot # 64858230, 64923245; T005089M:UDI:07460691959545/Lot #64933442, 65060364 T005091M:UDI:07460691959552/Lot # 64807926 T434501B:UDI: 07460691956636/ Lot # 64817812 T440B26B:UDI:07460691949553/ Lot # 64817809, 64817936; T450545A:UDI: 07460691931572/ Lot # 65035081; T460241A: UDI:07460691949188/ Lot # 64933451; T530219D:UDI:07460691948259/ Lot # 65067546
Where was it sold?
US: 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 OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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