The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0530-2025·Announced 2024-12-04

AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall

Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.

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 is an FDA Class II medical device recall involving mislabeled packaging of a surgical implant component. While the hazard is significant—patients could receive the wrong device component—no illnesses, injuries, or hospitalizations have been reported. Per the rubric, recalls with risk-of-harm where injury has not yet been reported score 3.

Plain-English summary

Boston Scientific Corporation is recalling 16 units of the AMS Artificial Urinary Sphincter Control Pump (UPN 72400098, Lot 32487464) distributed worldwide. The devices have an expiration date of September 24, 2028.

The recall is due to mislabeled packaging in which devices labeled as a Pressure Regulating Balloon (UPN 72400024) actually contained Control Pump units instead. This mislabeling could result in the wrong device component being implanted if the packaging is not carefully verified before use.

The affected units were distributed in the United States (Arizona, California, Colorado, Florida, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, New York, Oregon, Pennsylvania, Texas, Virginia, Washington) and internationally in Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.

Patients who may have received one of the affected units should contact their healthcare provider or Boston Scientific immediately. Healthcare providers should verify the contents of any received packages against the labeling and quarantine any units with discrepancies.

The recalled product

Product
AMS Artificial Urinary Sphincter Control Pump
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Implant
Hazard
Affected units
16

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 (15)

  • 1100366316
  • 1100366309
  • 1100366317
  • 1100366310
  • 1100366319
  • 1100366311
  • 1100366320
  • 1100366312
  • 1100366321
  • 1100366313
  • 1100366323
  • 1100366314
  • 1100366324
  • 1100366315
  • 1100366325. Expiration Date: 09/24/2028

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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 →

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