Reported Dec 6, 2023 · Ongoing
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
38 of 38 products
| # | Product as published |
|---|---|
| 1 | TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm) |
| 2 | PXVK0853: x3 (3cc)/VAMP 76in (193cm) |
| 3 | PXVK0996:(3cc)/VAMP 68in (174cm) |
| 4 | PXVMP2X21: x2 (3cc)/VAMP |
| 5 | PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm) |
| 6 | PXVMP3X32: x3 (3cc)/VAMP 75in (190cm) |
| 7 | PXVP0041: (3cc)/VAMP Plus 96in (244cm) |
| 8 | PXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm) |
| 9 | PXVP1071: x3 (3cc)/VAMP Plus 87in (221cm) |
| 10 | PXVP1087: x4(3cc)/VAMP Plus |
| 11 | PXVP2260: (3cc)/VAMP Plus 60in (150cm) |
| 12 | PXVP2272: (3cc)/VAMP Plus 72in (180cm) |
| 13 | PXVP2284: (3cc)/VAMP Plus 84in (210cm) |
| 14 | PXVP2284AT3: (3cc)/VAMP Plus 84in (210cm) |
| 15 | PXVP23X3: x3: (3cc)/VAMP Plus |
| 16 | PXVP23X3AT3: x3 (3cc)/VAMP Plus |
| 17 | PXVP2X2AT3: x2 (3cc)/VAMP Plus |
| 18 | PXVPL0111: (3cc)/VAMP Plus 84in (213cm) |
| 19 | PXVMP160: 3cc/VAMP 60 in (150cm) |
| 20 | PXVMP172: 3cc/VAMP 72in)180cm) |
- Lot codes and dates
36 of 36 products
Products covered by this recall # Barcodes Product as published 1 0069010301149400690103011494/Lot # 64817849 2 07460691950085PXAVMP3: UDI:07460691950085/Lot # 64918575 3 07460691954526PXVK0364:UDI:07460691954526/Lot # 64858007 4 07460691957671PXVK0853: UDI: 07460691957671/Lot # 65060361 5 07460691955431PXVK0996:UDI: 07460691955431/Lot # 64858275 6 07460691950115PXVMP2X21:UDI: 07460691950115/Lot # 64992080 7 00690103016765PXVMP2X22: UDI: 00690103016765/Lot # 64891427 8 0690103016802PXVMP3X32:UDI: 0690103016802/Lot # 65008748 9 00690103197983PXVP0041: UDI: 00690103197983/Lot # 64835537 10 07460691949911PXVP0550:UDI: 07460691949911/Lot # 64818013, 64858077, 64891424, 64918588, 64985484 11 07460691955462PXVP1071: UDI: 07460691955462/Lot # 64807998, 64807999 12 07460691957886PXVP1087: UDI: 07460691957886/Lot # 65035078, 65079515 13 07460691950108PXVP2260: UDI: 07460691950108/Lot # 64858071, 64858103, 64891419, 64906892 14 07460691950184PXVP2272:UDI: 07460691950184/Lot # 64752261, 64906891, 65138017 15 07460691950177PXVP2284: UDI: 07460691950177/Lot # 64818005, 64818008, 64818011, 64891421, 64933492, 64933493, 64964755, 64964759, 64964760, 64964761, 64998878, 65060446 16 07460691950436PXVP2284AT3: UDI: 07460691950436/Lot # 64722680, 64858285, 64951434, 64980108, 64992088 17 07460691950092PXVP23X3:UDI: 07460691950092/Lot # 64998879, 65060444 18 07460691950443PXVP23X3AT3: UDI: 07460691950443/Lot # 64695848, 64779289, 64858072, 64858290, 64992092,65060447 19 07460691950467PXVP2X2AT3: UDI:07460691950467/Lot # 64858075 20 00690103200386PXVPL0111: UDI: 00690103200386/Lot # 64933462 - Amount recalled
- 168,014 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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