Edwards Lifesciences, LLC: 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)

Recall number

Z-0414-2024

Recalling firm

Edwards Lifesciences, LLC

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)

Status

Open, Classified

Initiated

2023-10-04

Posted

2023-11-29

Terminated

not on file

Reason

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Root cause

Device Design

Action

On 10/18/2023, Edwards Lifesciences issued a "Urgent: Medical device Correction Action via FedEx mail. Edwards ask consignees to take the following actions: 1. Follow the IFU for proper setup and flushing of your device. 2. Follow the instructions included in the enclosed customer acknowledgement form to complete the acknowledgement process. 3. Verify your inventory on the attached customer acknowledgement form. 3a.E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com, within 15 days from receipt of this notification. 4. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. 5. Please post a copy of this notice near and/or with affected devices. 6. Contact Edwards Customer Service at 1-888-352-0904 if you would like to return any of your devices or have further questions. 7. Action Requested for Distributors: In addition to the actions above, please forward this customer communication to any of your customers who have purchased the impacted product.

Quantity

168,014 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K142749","K181684","K183413","K896819"]

PMA numbers

not on file

Product code

DRS

Firm FEI

2015691

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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