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 Pl Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Pl
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
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, 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, 64817936, T450545A:UDI: 07460691931572/ Lot # 65035081, T460241A: UDI:07460691949188/ Lot # 64933451, T530219D:UDI:07460691948259/ Lot # 65067546
Products Sold
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
Edwards Lifesciences, LLC is recalling TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 ( due to Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026