Uphold LITE with Capio SLIM Vaginal Support System (2019-04-25)

Starting date:
April 25, 2019
Posting date:
May 10, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69894

Last updated:

Affected Products

Uphold LITE with Capio SLIM Vaginal Support System

Reason

The FDA ordered all manufacturers of surgical mesh for transvaginal repair of pelvic organ prolapse to stop selling products immediately and withdraw all products from the US market. The FDA does not believe sufficient clinical evidence is available to assure the benefits of these devices outweigh their probable risks.

Affected products

Uphold LITE with Capio SLIM Vaginal Support System

Lot or serial number
  • 21124236
  • 21336724
  • 21377535
  • 21447170
  • 21496403
  • 21598241
  • 21712236
  • 21719811
  • 21724597
  • 21766448
  • 21781540
  • 21951557
  • 22189634
  • 32829
  • 41745
  • 42876
  • 47878
  • 53304
  • 54926
  • 56826
Model or catalog number
  • M0068318170
Companies
Manufacturer
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES