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: 2019-05-10
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