FDA Devices recall · Reported April 28, 2021
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
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Boston Scientific Corporation recalled The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing salin… - a moderate-severity action.
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing salin… was recalled by Boston Scientific Corporation in April 28, 2021. Reason: An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir w…. Check the official notice for the remedy. Verify recall #Z-1433-2021 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this moderate-severity FDA Devices recall-An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir w….
- Moderate
- severity level
- 23 units
- affected scope
- Class II
- classification
- April 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1433-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
Reason for recall
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1433-2021 |
| Date reported | April 28, 2021 |
| Date initiated | March 26, 2021 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Marlborough, MA |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1433-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026