Capio and Capio SLIM Suture Capturing Device, Uphold Vaginal Support System, Uphold LITE with Capio SLIM, and Pinnacle Pelvic Floor Repair Kit - Posterior (2018-02-15)
- Starting date:
- February 15, 2018
- Posting date:
- March 23, 2018
- 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-66244
Affected products
A. CAPIO SUTURE CAPTURING DEVICE
B. UPHOLD VAGINAL SUPPORT SYSTEM
C. PINNACLE PELVIC FLOOR REPAIR KIT - POSTERIOR
D. CAPIO SLIM SUTURE CAPTURING DEVICE
E. UPHOLD LITE WITH CAPIO SLIM
Reason
Increasing trend in reports regarding the Capio suture breakage and/or detachment of the Capio suture darts from both the Capio suture and the pelvic floor kit mesh assembly (Uphol Vaginal Support System, Uphold LITE Vaginal Support System, Pinnacle Anterior Pelvic Floor Repair Kit, Pinnacle Posterior Pelvic Floor Repair Kit).
Affected products
A. CAPIO SUTURE CAPTURING DEVICE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M0068311251
M0068312321
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
B. UPHOLD VAGINAL SUPPORT SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M0068317080
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
C. PINNACLE PELVIC FLOOR REPAIR KIT - POSTERIOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M0068317100
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
D. CAPIO SLIM SUTURE CAPTURING DEVICE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M0068318250
M0068318261
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
E. UPHOLD LITE WITH CAPIO SLIM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M0068318170
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES