CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
Edwards TruWave x 2 (3 cc)/VAMP Jr/ (136) Kit recalled
Edwards Lifesciences is recalling Edwards TruWave x 2 (3 cc)/VAMP Jr/ (136) 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-1961-2021
- 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
- Other Reasons
- 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
Product as listed by the FDA
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
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
Why was it recalled?
There is a potential that the pressure tubing may detach from the blood sampling system
Which lots are affected?
Lot # 63479666- Not Marketed within the US
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 87993| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Edwards TruWave 3 cc/VAMP Jr Kit recalled by Edwards Lifesciences | Edwards Lifesciences | Other | 29 states | |
| CLASS II | Edwards VAMP Jr recalled by Edwards Lifesciences | Edwards Lifesciences | Other | 29 states | |
| CLASS II | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use recalled | Edwards Lifesciences | Other | 29 states | |
| CLASS II | Edwards TruWave (3 cc)/VAMP Jr recalled by Edwards Lifesciences | Edwards Lifesciences | Other | 29 states | |
| CLASS II | Edwards TruWave (30 cc)/VAMP Jr/ Kit recalled by Edwards Lifesciences | Edwards Lifesciences | Other | 29 states | |
| CLASS II | Edwards TruWave (30 cc)/VAMP Jr Kit recalled by Edwards Lifesciences | Edwards Lifesciences | Other | 29 states | |
| CLASS II | Edwards TruWave (3 cc)/VAMP Jr Kit recalled by Edwards Lifesciences | Edwards Lifesciences | Other | 29 states |
More recalls from Edwards Lifesciences
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Edwards Evoque tricuspid delivery system recalled | Edwards Lifesciences | Other | Nationwide |
| Device | CLASS I | Optisite Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
Other Patient Monitors recalls
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|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |