American Medical Systems Recalls AMS 700 Series Inflatable Penile Prosthesis Accessory Kits
American Medical Systems is recalling AMS 700 Series Accessory Kits because supplier-supplied Keith needles may bend or break when used with the Furlow tool.
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 potential mechanical failure (bent or broken needle) in a medical device used during surgery, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
American Medical Systems, Inc. is recalling the AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), catalog number 72401850. The recall involves 184 units distributed in the United States and internationally. The Keith Needles included in these kits are used in conjunction with the Furlow Insertion Tool to facilitate the passing of pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
The recall was initiated after the supplier of the Keith needles issued a recall for certain lots of these needles. This action followed an internal investigation requested by American Medical Systems, which identified a potential nonconformity. The investigation determined that the needles may bend or break when used with the Furlow tool.
The affected products were distributed nationwide in the United States, including Puerto Rico, and in several international countries including Argentina, Australia, Brazil, Canada, Germany, France, Great Britain, Lebanon, Panama, Solomon Islands, Sweden, and Colombia. Consumers and healthcare providers should stop using the affected accessory kits and contact American Medical Systems for further instructions.
The recalled product
- Product
- AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures…
- Manufacturer
- American Medical Systems, Inc.
Distribution
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