Boston Scientific AMS 700 MS Pump Recall for Activation Difficulties
Boston Scientific is recalling AMS 700 MS Pumps due to reports of difficulty activating the device to inflate cylinders.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (device failure) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling the AMS 700 MS Pump, an inflatable penile prosthesis component, in the United States and internationally. The recall affects 24,064 units sold as individual units or pre-connected to AMS 700 cylinders.
The recall was initiated because the firm observed an increase in complaints regarding problems during the initial activation of the device. Specifically, patients and physicians have reported being unable or having difficulty activating the pump to achieve cylinder inflation.
The affected devices are distributed domestically in the United States and in numerous foreign countries, including Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, and the United Kingdom. Consumers and healthcare providers should check the product's Unique Product Number (UPN) or serial number against the list provided by Boston Scientific to determine if their device is impacted. Affected users should contact Boston Scientific for instructions on replacement or repair.
The recalled product
- Product
- AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 24,064
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- visit: www.bostonscientific.com/lookup
Distribution
Distributed nationwide across the United States.
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