Edwards Lifesciences, LLC TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3c Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3c
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
PX212: UDI: 07460691950221/Lot # 65087613, PX260: UDI: 07460691950191/Lot #64817892, 64818036, 64818038, 64964776, 64964780, PX272: UDI: 07460691950207/Lot # 65067588 PX284: UDI: 07460691950214/Lot # 64980120, 64980121, 65008760, 65019888, 65019889, 65035079, PX2X2: UDI: 07460691950061/Lot # 64955114, 65012789, 65027868, 65170585, PX3X3284C:UDI: 07460691950269/Lot # 64906878, 65007202, 65019845, PX4X4: UDI: 07460691950665/Lot # 64807960, 64835551, 64858629, PX600F: UDI: 07460691945555/Lot # 64918553, 64951413, 65016989, PXMK1876: UDI: 07460691953826/Lot # 64817828, 64817963, PXMK1940: UDI: 07460691955981/Lot # 64858039, PXMK2024: UDI: 07460691958180/Lot # 64964690, PXMK2041: UDI: 07460691951464/Lot # 64933443, 64933444, PXMK2321: UDI: 07460691958784/Lot # 64912231, PXMK2331: UDI: 07460691959224/Lot # 64933498, PXMK9146: UDI: 07460691954427/Lot # 64992075, PXMK1876: UDI: 07460691953826/Lot # 64817963, 64807966, 64918558, 64948620, T001658A :UDI: 07460691902053/Lot #65007203, 65036124, T001660A: UDI: 07460691902077/Lot # 64964732, 65019857, T001709A: UDI: 07460691947610/Lot# 64918560, 64964727, 65079483, T001767A: UDI: 07460691947306/Lot # 64891376, 64906871, 64980035, 64983290, 65035029, T321573A: UDI: 07460691910270/Lot# 64807975, T433803A: UDI: 07460691926714/Lot # 64722635, T441T01C: UDI: 07460691928848/Lot # 64835565, T494C00B:UDI: 07460691950313/Lot #64807969, 64918562
Products Sold
PX212: UDI: 07460691950221/Lot # 65087613; PX260: UDI: 07460691950191/Lot #64817892, 64818036, 64818038, 64964776, 64964780; PX272: UDI: 07460691950207/Lot # 65067588 PX284: UDI: 07460691950214/Lot # 64980120, 64980121, 65008760, 65019888, 65019889, 65035079; PX2X2: UDI: 07460691950061/Lot # 64955114, 65012789, 65027868, 65170585; PX3X3284C:UDI: 07460691950269/Lot # 64906878, 65007202, 65019845; PX4X4: UDI: 07460691950665/Lot # 64807960, 64835551, 64858629; PX600F: UDI: 07460691945555/Lot # 64918553, 64951413, 65016989; PXMK1876: UDI: 07460691953826/Lot # 64817828, 64817963; PXMK1940: UDI: 07460691955981/Lot # 64858039; PXMK2024: UDI: 07460691958180/Lot # 64964690; PXMK2041: UDI: 07460691951464/Lot # 64933443, 64933444; PXMK2321: UDI: 07460691958784/Lot # 64912231; PXMK2331: UDI: 07460691959224/Lot # 64933498; PXMK9146: UDI: 07460691954427/Lot # 64992075; PXMK1876: UDI: 07460691953826/Lot # 64817963; PXVK1099: UDI: 07460691958753 /Lot # 65067568 PXMK0102: UDI: 00690103199932/ Lot # 65008741 PXMK2043: UDI: 07460691956230/ Lot # 64980031 T001657A: UDI: 07460691902046/Lot# 64686945, 64807966, 64918558, 64948620; T001658A :UDI: 07460691902053/Lot #65007203, 65036124; T001660A: UDI: 07460691902077/Lot # 64964732, 65019857; T001709A: UDI: 07460691947610/Lot# 64918560, 64964727, 65079483; T001767A: UDI: 07460691947306/Lot # 64891376, 64906871, 64980035, 64983290, 65035029; T321573A: UDI: 07460691910270/Lot# 64807975; T433803A: UDI: 07460691926714/Lot # 64722635; T441T01C: UDI: 07460691928848/Lot # 64835565; T494C00B:UDI: 07460691950313/Lot #64807969, 64918562;
Edwards Lifesciences, LLC is recalling TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc 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