Z-1433-2021Class II

The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is...

Name: Z-1433-2021 The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is...
Creator: Boston Scientific Corporation
Published: 2021-03-26
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-03-26 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main... on 2021-03-26. FDA classified it as Class II and gives the reason as "An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone". 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-1433-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-26
Posted: 2021-04-16
Terminated: 2024-03-04
Recalling firm: Boston Scientific Corporation
Product: The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156
Product code: JCW Prosthesis, Penis, Inflatable
Reason for recall: An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 3/25/2021, BCS issued an Urgent Medical Device Removal notice via letter to customers notifying them certain serial numbers of AMS 700 Reservoirs may have been incorrectly labeled.
Quantity in commerce: 23 units
Distribution: Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal
Product codes and lots: Lot: 26147100, 26154112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1433-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1433-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-16

Product code JCW

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)