# FDA recall Z-1964-2021

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2021-05-26.

## Product

Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI:  (01)57460691950370

## 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

## Key facts

- **Recall number:** Z-1964-2021
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-26
- **Report date:** 2021-07-07
- **Termination date:** 2023-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2021

## Citation

> AI Analytics. FDA recall Z-1964-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1964-2021. Source: US FDA. Licensed CC0.

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