# FDA recall Z-2744-2018

> **ConvaTec, Inc** · Class II · device recall initiated 2018-07-03.

## Product

AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301     AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

## Reason for recall

Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.

## Distribution

worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Canada, Bahrain, Bangladesh, Belgium, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Kenya, Kuwait, Malta, Mauritius, Netherlands,Norway, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.

## Key facts

- **Recall number:** Z-2744-2018
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-03
- **Report date:** 2018-08-22
- **Termination date:** 2023-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2744-2018

## Citation

> AI Analytics. FDA recall Z-2744-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2744-2018. Source: US FDA. Licensed CC0.

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