Z-2442-2019Class II

AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161

Name: Z-2442-2019 AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Creator: Boston Scientific Corporation
Published: 2019-07-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-07-19 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161 on 2019-07-19. FDA classified it as Class II and gives the reason as "Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2442-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-08-30
Terminated: 2020-04-23
Recalling firm: Boston Scientific Corporation
Product: AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Product code: EZY Device, Incontinence, Mechanical/Hydraulic
Reason for recall: Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Boston Scientific contacted customer via the sales representative on July 19, 2019. The removal letter was given to the customer by the sales representative. The letter states reason for recall, health risk and Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific
Quantity in commerce: 1 unit
Distribution: MN
Product codes and lots: Lot Number: 23973023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2442-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2442-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code EZY

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)