Z-2045-2020Class II

AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 -

Name: Z-2045-2020 AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 -
Creator: Boston Scientific Corporation
Published: 2019-12-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-12-17 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile... on 2019-12-17. FDA classified it as Class II and gives the reason as "A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone". 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-2045-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-17
Posted: 2020-01-28
Terminated: 2020-06-04
Recalling firm: Boston Scientific Corporation
Product: AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Product code: JCW Prosthesis, Penis, Inflatable
Reason for recall: A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On December 17, 2019, the firm sent an Urgent Medical Device Product Advisory letter to affected customers. Customers were informed of the labeling mix-up and instructed to add the advisory notice to the patient record. Customers were also asked to complete and returned an enclosed acknowledgement form. Customers with questions should contact their local Sales Representative.
Quantity in commerce: 5
Distribution: US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Product codes and lots: Lot 24464037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2045-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2045-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-19

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)