| Class 2 Device Recall Uphold Vaginal Support System | |
Date Initiated by Firm | February 12, 2018 |
Date Posted | May 04, 2018 |
Recall Status1 |
Terminated 3 on April 10, 2020 |
Recall Number | Z-1626-2018 |
Recall Event ID |
79608 |
510(K)Number | K081048 |
Product Classification |
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
|
Product | Uphold Vaginal Support System; Model #M0068317080.
Indicated for tissue reinforcement in women with pelvic organ prolapse. |
Code Information |
GTIN: 08714729773955. Batch numbers: ML00002892 ML00003166 ML00003060 ML00003291 ML00003119 ML00003435 ML00003516 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
|
For Additional Information Contact | Nicole Pshon 763-494-1133 |
Manufacturer Reason for Recall | Potential for Capio sutures to break and /or detach. |
FDA Determined Cause 2 | Device Design |
Action | Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices. |
Quantity in Commerce | 1,002 |
Distribution | Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark,
Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama,
Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic,
Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia,
Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia,
Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta,
Namibia, Romania, Switzerland, and Greece. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = PWI
|
|
|
|