Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA device recall Z-1622-2018 · posted 2018-05-04 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential for Capio sutures to break and /or detach.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- PWI
- Quantity affected
- 24,126
- Distribution
- Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, I
- Date initiated
- 2018-02-12
- Date posted
- 2018-05-04
- Date terminated
- 2020-04-10
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM (K122459) | Boston Scientific Corporation | 2012-12-13 |