ConvaTec AbViser AutoValve IAP Monitoring Device Recall: Pinhole Breach Risk
ConvaTec recalls AbViser AutoValve IAP monitoring devices (REF ABV300/ABV301) due to potential pinhole breaches in sterile barriers. Affected units may leak fluid during use.
Lower-risk recall
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
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What happened, in plain English
ConvaTec is recalling AbViser AutoValve IAP monitoring devices with model numbers ABV300 and ABV301 because they might have pinholes in their sterile barriers. This could allow fluid to leak during use, potentially causing infection or other complications. Read more at govinfonow.com/recall/70672-convatec-abviser-autovalve-iap-monitoring-device-recall-pinhole-breach-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/70672-convatec-abviser-autovalve-iap-monitoring-device-recall-pinhole-breach-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2744-2018
Cite this page
“ConvaTec AbViser AutoValve IAP Monitoring Device Recall: Pinhole Breach Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70672-convatec-abviser-autovalve-iap-monitoring-device-recall-pinhole-breach-risk. Based on FDA recall #Z-2744-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2744-2018%22&limit=1).
Why it’s dangerous
The device's sterile barrier might develop pinholes during use, allowing fluid to leak. This could lead to infections or other complications if the device is not properly sealed.
Who’s affected
Patients using the AbViser AutoValve IAP monitoring device for intra-abdominal pressure measurement are affected. Healthcare providers and patients with urinary catheters are most at risk.
How to tell if you have this one
Check for model numbers ABV300 or ABV301 on the device. Lot numbers for ABV300 is 150924, and for ABV301 are 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829.
- Brand
ConvaTec- Category
Medical device
What to do — step by step
Check Device Model
Look for model numbers ABV300 or ABV301 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 4.6 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-2744-2018 (July 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2744-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.