Home / Recalls / Boston Scientific Corporation / Z-0427-2021

Z-0427-2021 Class II Ongoing

Recalled by Boston Scientific Corporation — Marlborough, MA

FDA device recall Z-0427-2021 was initiated by Boston Scientific Corporation on September 24, 2020 and is designated Class II. 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 acti… The recall status is ongoing. Affected quantity: 24,064.

Recall Details

Product Type
Devices
Report Date
November 18, 2020
Initiation Date
September 24, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,064

Product Description

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 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

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

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  • Z-2840-2026 Class II — Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: (June 30, 2026)
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  • Z-2752-2026 Class II — FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation (June 11, 2026)
  • Z-2750-2026 Class II — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4 (June 11, 2026)
  • Z-2755-2026 Class II — FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature a (June 11, 2026)
  • Z-2753-2026 Class II — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4 (June 11, 2026)
  • Z-2754-2026 Class II — FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculatu (June 11, 2026)

FDA data resources