AbViser AutoValve IAP — Class II medical device recall Z-2744-2018
Terminated recall by ConvaTec, Inc, reported 2018-08-22, distributed nationwide. Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for
| Recall number | Z-2744-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2018-07-03 |
| Classified | 2018-08-10 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2023-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BH, CA, CH, CL, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GB, HR, HU, IL, IN, IT, KE, KR, KW, MT, NL, NO, PT, QA, RO, SA, SE, SG, SI, TR, TW, VN, ZA |
| Quantity | 3,881 units |
| Reason classes | sterility, packaging |
| Lot numbers | 150924, 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829 |
| Model numbers | ABV300, ABV301 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2744-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.