Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86562

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 24, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0427-2021
Recall number
Z-0427-2021
Initiated
September 24, 2020
Classification
Class II
Status
Ongoing
Quantity
24,064

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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