# FDA recall Z-0427-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-09-24.

## Product

AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis

## Reason for recall

The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.

## Distribution

Domestic distribution nationwide. Foreign distribution to Argentina  Ecuador  Lebanon  Saudi Arabia  Australia  Estonia  Malaysia  Serbia  Austria  Finland  Malta  Singapore  Bahrain  France  Mexico  Slovenia  Belarus  Germany  Netherlands  South Africa  Belgium  Great Britain  New Zealand  South Korea  Brazil  Greece  Norway  Spain  Canada  Guatemala  Panama  Sweden  Chile  Hong Kong  Poland  Switzerland  China  India  Portugal  Taiwan  Colombia  Iran  Puerto Rico  Thailand  Costa Rica  Ireland  Qatar  Turkey  Croatia  Israel  Romania  United Arab Emirates  Czech Republic  Italy  Russian Fed.  Dominican Republic

## Key facts

- **Recall number:** Z-0427-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-24
- **Report date:** 2020-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0427-2021

## Citation

> AI Analytics. FDA recall Z-0427-2021. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/Z-0427-2021. Source: US FDA. Licensed CC0.

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