CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
AMS 700, Spherical Reservoir with InhibiZone recalled
Boston Scientific is recalling AMS 700, Spherical Reservoir with InhibiZone, distributed nationwide in the US. The recall was initiated on 17 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2045-2020
- FDA event ID
- 84739
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2019
- FDA classified
- 19 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 17 Dec 2019 | Recall initiated by company | |
| 19 May 2020 | Classified by FDA | +154 days |
| 27 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Questions about this recall
Why was it recalled?
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Which lots are affected?
Lot 24464037
Where was it sold?
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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