Recall Z-0414-2024 ยท DRS Transducer, Blood-Pressure, Extravascular
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 (231
| Date | Nov 29, 2023 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| 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 |
| 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 I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142749 | TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC, Jan 18, 2015 |
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC, Nov 8, 2018 |
| K183413 | TruWave Disposable Pressure Transducer Edwards Lifeciences, LLC, May 1, 2019 |
| K896819 | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION Baxter Healthcare Corp, Jan 19, 1990 |