Edwards TruWave x2 Pressure Monitoring Kit Recall: Risk of Tubing Detachment
Edwards recalls specific pressure monitoring kits for potential tubing detachment during blood sampling. This recall applies to CE-marked kits sold outside the US with UDI 01 57460691930174. No action is required as the kits are not marketed in the US.
Recall notice
There is a potential that the pressure tubing may detach from the blood sampling system
Contact the company
What happened, in plain English
Edwards is recalling a specific pressure monitoring kit used for blood sampling that may detach the pressure tubing. This could cause injury during medical procedures. The kits are not sold in the US, so no action is needed for US customers. Read more at govinfonow.com/recall/62473-edwards-truwave-x2-pressure-monitoring-kit-recall-risk-of-tubing.
Source Summary by GovInfoNow · govinfonow.com/recall/62473-edwards-truwave-x2-pressure-monitoring-kit-recall-risk-of-tubing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1961-2021
Cite this page
“Edwards TruWave x2 Pressure Monitoring Kit Recall: Risk of Tubing Detachment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62473-edwards-truwave-x2-pressure-monitoring-kit-recall-risk-of-tubing. Based on FDA recall #Z-1961-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1961-2021%22&limit=1).
Why it’s dangerous
The pressure tubing might detach from the blood sampling system during use, potentially causing injury. This risk occurs in medical procedures where the tubing is connected to a patient's blood flow.
Who’s affected
Patients using this specific pressure monitoring kit for blood sampling in medical settings outside the US. US customers are not affected as the kits are not marketed there.
How to tell if you have this one
Check for the kit name 'Edwards TruWave x2 (3 cc)/VAMP Jr/54 in (136) Kit' with reference number T443952B. The kits are CE-marked and sterilized with ethylene oxide. They were not marketed in the US.
- Brand
Edwards- Product
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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; Lot #s: 63505216 and 63590087 | 460 units |
| 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; Lot #s: 63470654, 63505217 and 63592430 | 700 units |
| 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; Lot # 63479666- Not Marketed within the US | 290 units |
| Z-1962-2021 | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520; Lot # 63456332 | 2,000 units |
| 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; Lot # 63445142 and 63630816 | 1,679 units |
| Z-1964-2021 | Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370; Lot # 63438489 | 990 units |
| Z-1965-2021 | Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547; Lot # 63598812 | 50 units |
| Z-1966-2021 | Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746; Lot # 63545959 | 90 units |
What to do — step by step
Check Kit Details
Look for the reference number T443952B and CE marking on the kit packaging.
Where it went and when
Where it was distributed
Distributed in 31 states and D.C. and Puerto Rico, and outside the U.S.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, North Carolina, North Dakota, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1961-2021 (May 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1961-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.