Z-2744-2018Class II

AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF...

Name: Z-2744-2018 AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF...
Creator: ConvaTec, Inc
Published: 2018-07-03
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2018-07-03 / Terminated / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable... on 2018-07-03. FDA classified it as Class II and gives the reason as "Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2744-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Posted: 2018-08-10
Terminated: 2023-01-24
Recalling firm: ConvaTec Limited
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.
Product code: FEN Device, Cystometric, Hydraulic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, ConVaTec, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter dated July 2, 2018, to its customers via United Parcel Service of America (UPS) Ground with tracking on July 3, 2018, with emails sent to distributors on July 9, 2018. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. Inspect your inventory to confirm if you have any of the affected product codes. 2 Perform a count of affected product currently in inventory. Complete the enclosed response form and return it to the address on the response form. Return the attached Recall Response Form even if no affected product is in inventory. 3 If you have any affected product in inventory please contact [email protected] or call the Customer Interaction Center at the toll free number 1-800-422-8811. You will be provided further instructions regarding how to return affected product and arrange credit.
Quantity in commerce: 3881 units
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.
Product codes and lots: a) ABV 300: Lot Number 150924 b) ABV 301: Lot Numbers: 160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2744-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2744-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10

Product code FEN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)