Boston Scientific recalls AMS 700 penile prosthesis reservoirs mislabeled as 100 mL Conceal when they are 100 mL Spherical. This affects specific lot numbers and part numbers.
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Boston Scientific is recalling certain AMS 700 inflatable penile prosthesis reservoirs that were incorrectly labeled. This mislabeling could lead to improper use if someone assumes it's a different type of reservoir.
The reservoirs were mislabeled as 100 mL Conceal when they are actually 100 mL Spherical. This could cause confusion during use if someone assumes the reservoir is a different type, potentially leading to improper use.
Men who own or use the AMS 700 penile prosthesis with specific part numbers (720185-01, 72404156) and lot numbers (26147100, 26154112) are affected. Those most at risk are users who might not notice the label difference.
Check for part numbers 720185-01 or 72404156 and lot numbers 26147100 or 26154112 on the reservoir packaging. The product is a closed fluid-filled system for penile prostheses.
Look for part numbers 720185-01 or 72404156 and lot numbers 26147100 or 26154112 on the reservoir packaging.
The AMS 700 is a closed fluid-filled system containing saline, made of silicone, with a pump, two cylinders, a fluid reservoir, and kink-resistant tubing for creating erections in men with chronic erectile dysfunction.
The reservoir was incorrectly labeled as a 100 mL Conceal Reservoir when it is actually a 100 mL Spherical Reservoir.
Check the reservoir packaging for part numbers 720185-01 or 72404156 and lot numbers 26147100 or 26154112. If you have these, contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1433-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1433-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
