Boston Scientific Corporation: Medical Device Recall in 2019 - (Recall #: Z-2442-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 19, 2019

Date Posted: September 11, 2019

Recall Number: Z-2442-2019

Event ID: 83567

Reason for Recall:

Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot Number: 23973023

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated