AMS Artificial Urinary Sphincter Balloon Mislabeled With Wrong Component
Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.
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: This FDA Class II medical device recall involves mislabeling that could result in the wrong component being used. No illnesses or injuries have been reported, fitting the rubric criteria for High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 52 units of AMS Artificial Urinary Sphincter Pressure Regulating Balloons due to mislabeled packaging. Devices labeled as UPN 72400024 (Pressure Regulating Balloon, 61-70 cm H2O) may instead contain a Control Pump (UPN 72400098).
The affected lot numbers are 32500739, 32500821, and 32500820. The recall affects 15 U.S. states and 20 international countries and territories worldwide.
Patients and healthcare providers with potentially affected devices should contact Boston Scientific Corporation to verify the contents of their devices. Specific serial numbers have been identified to locate affected units.
The recalled product
- Product
- AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 52
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 (20)
- UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739
- 32500821
- 32500820. Serial Numbers: 1100366088
- 1100366115
- 1100366089
- 1100366116
- 1100366090
- 1100366117
- 1100366091
- 1100366118
- 1100366092
- 1100366119
- 1100366093
- 1100366120
- 1100366094
- 1100366121
- 1100366095
- 1100366122
- 1100366096
- 1100366123
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateBoston Scientific Recalls Mislabeled AMS 800 Artificial Urinary Sphincter Cuffs
FDA (Devices) · 2019-09-11
- ModerateBoston Scientific Recalls AMS 700 Reservoirs Due to Labeling Error
FDA (Devices) · 2020-05-27
- ModerateAmerican Medical Systems Recalls AMS 800 Urinary Control System Components
FDA (Devices) · 2013-05-22
- ModerateAMS 800 Urinary Control System Components Recalled for Release Criteria Failures
FDA (Devices) · 2013-05-22
- ModerateBoston Scientific AMS 700 Penile Prosthesis Reservoirs Recalled for Mislabeling
FDA (Devices) · 2021-04-28
- ModerateBoston Scientific Retrieval Balloon Catheter Recalled for Labeling Error
FDA (Devices) · 2017-07-12