Food, drugs, devices › Edwards Lifesciences, LLC
Device recall: Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Steri
FDA enforcement event 87993 is a device recall by Edwards Lifesciences, LLC of Irvine, CA, initiated 26 May 2021 and classified Class II, with 8 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 14 Dec 2023. Initiation: voluntary: firm initiated. Edwards Lifesciences, LLC has 50 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Edwards Lifesciences, LLC, Irvine, CA.
Reason for recall
"There is a potential that the pressure tubing may detach from the blood sampling system"
Distribution
"US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1959-2021 | Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507 | 460 units | Class II | Terminated | 7 Jul 2021 |
| Z-1960-2021 | Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489 | 700 units | Class II | Terminated | 7 Jul 2021 |
| Z-1961-2021 | Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US | 290 units | Class II | Terminated | 7 Jul 2021 |
| Z-1962-2021 | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520 | 2,000 units | Class II | Terminated | 7 Jul 2021 |
| Z-1963-2021 | Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782 | 1,679 units | Class II | Terminated | 7 Jul 2021 |
| Z-1964-2021 | Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370 | 990 units | Class II | Terminated | 7 Jul 2021 |
| Z-1965-2021 | Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547 | 50 units | Class II | Terminated | 7 Jul 2021 |
| Z-1966-2021 | Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746 | 90 units | Class II | Terminated | 7 Jul 2021 |
Context
Other enforcement events for Edwards Lifesciences, LLC
All 50 events for Edwards Lifesciences, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential that the pressure tubing may detach from the blood sampling system"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Dec 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.