CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
Edwards TruWave (3 cc)/VAMP Jr Kit recalled by Edwards Lifesciences
Edwards Lifesciences is recalling Edwards TruWave (3 cc)/VAMP Jr Kit, distributed in 29 states. The recall was initiated on 26 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1959-2021
- FDA event ID
- 87993
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 May 2021
- FDA classified
- 25 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 26 May 2021 | Recall initiated by company | |
| 25 Jun 2021 | Classified by FDA | +30 days |
| 7 Jul 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential that the pressure tubing may detach from the blood sampling system
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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
ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontanaNorth CarolinaNorth DakotaNebraska
Questions about this recall
Is Edwards TruWave (3 cc)/VAMP Jr Kit recalled?
Yes. Edwards Lifesciences recalled Edwards TruWave (3 cc)/VAMP Jr Kit on 26 May 2021. The recall is Class II and its status is Terminated. Recall number Z-1959-2021.
Why was it recalled?
There is a potential that the pressure tubing may detach from the blood sampling system
Which lots are affected?
Lot #s: 63505216 and 63590087
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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