Boston Scientific AMS 700 Penile Prosthesis Reservoirs Recalled for Mislabeling
Boston Scientific is recalling 23 AMS 700 penile prosthesis reservoirs because they were incorrectly labeled as a different model type.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 23 units of the AMS 700 Inflatable Penile Prosthesis. The specific components involved are 100 mL Spherical Reservoirs with InhibiZone that were incorrectly labeled as 100 mL Conceal Reservoirs with InhibiZone. The AMS 700 is a closed fluid-filled system containing saline, made of silicone, and used to create an erection in men with chronic, organic, erectile dysfunction.
The recall is due to a labeling error where the spherical reservoirs were identified as conceal reservoirs. The affected units were distributed worldwide, including in the United States (AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT) and in Belgium, France, and Portugal. The specific lot numbers involved are 26147100 and 26154112.
Consumers and healthcare providers should contact Boston Scientific Corporation for further instructions regarding the replacement or return of these mislabeled components.
The recalled product
- Product
- The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 23
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 (2)
- Lot: 26147100
- 26154112
Distribution
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