Reported Nov 18, 2020 · Ongoing
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders.…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
- Lot codes and dates
- UPNsTo determine if a UPN/serial number is impacted
7240431072404280724042817240428272404282-107240428372404283-127240428472404284-14724042857240428672404287724042887240428972404300724043017240430272404302-107240430372404303-1272404305724043067240430772404308724042097240426072404261724042627240426372404264724042657240426672404267724042687240426972404230724042317240423272404232-107240423372404233-127240423472404234-14724042357240423672404237724042387240423972404250724042517240425272404252-107240425372404253-1272404255724042567240425772404258
- visitwww.bostonscientific.com/lookup
- UPNs
- Amount recalled
- 24,064
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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