Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device Recalled by ConvaTec, Inc Due to Bubble Leak Testing on AbViser AutoValve IAP Monitoring...

Date: July 3, 2018
Company: ConvaTec, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ConvaTec, Inc directly.

Affected Products

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.

Quantity: 3881 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ConvaTec, Inc

ConvaTec, Inc has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report