CLASS II ONGOING Device recall · Reported 18 Nov 2020 · FDA Enforcement Report

AMS 700 MS Pump with and without InhibiZone recalled

Boston Scientific is recalling AMS 700 MS Pump with and without InhibiZone, sold as individual units and also, distributed nationwide in the US. The recall was initiated on 24 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPNs 72404310 72404280 72404281 72404282 72404282-10 72404283 72404283-12 72404284 72404284-14 72404285 72404286 72404287 72404288 72404289 72404300 72404301 72404302 72404302-10 72404303 72404303-12 72404305 72404306 72404307 72404308 72404209 72404260 72404261 72404262 72404263 72404264 72404265 72404266 72404267 72404268 72404269 72404230 72404231 72404232 72404232-10 72404233 72404233-12 72404234 72404234-14 72404235 72404236 72404237 72404238 72404239 72404250 72404251 72404252 72404252-10 72404253 72404253-12 72404255 72404256 72404257 72404258 To determine if a UPN/serial number is impacted, visit: www.bostonscientific.com/lookup

Quantity recalled24,064

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-0427-2021
FDA event ID: 86562
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Sep 2020
FDA classified: 6 Nov 2020
Reported: 18 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Sep 2020	Recall initiated by company
6 Nov 2020	Classified by FDA	+43 days
18 Nov 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Is AMS 700 MS Pump with and without InhibiZone, sold as individual units and also recalled?

Yes. Boston Scientific recalled AMS 700 MS Pump with and without InhibiZone, sold as individual units and also on 24 Sep 2020. The recall is Class II and its status is Ongoing. Recall number Z-0427-2021.

Why was it recalled?

Which lots are affected?

UPNs 72404310 72404280 72404281 72404282 72404282-10 72404283 72404283-12 72404284 72404284-14 72404285 72404286 72404287 72404288 72404289 72404300 72404301 72404302 72404302-10 72404303 72404303-12 72404305 72404306 72404307 72404308 72404209 72404260 72404261 72404262 72404263 72404264 72404265 72404266 72404267 72404268 72404269 72404230 72404231 72404232 72404232-10 72404233 72404233-12 72404234 72404234-14 72404235 72404236 72404237 72404238 72404239 72404250 72404251 72404252 72404252-10 72404253 72404253-12 72404255 72404256 72404257 72404258 To determine if a UPN/serial number is impacted, visit: www.bostonscientific.com/lookup

Where was it sold?

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 21 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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