—#208820

Product

Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.

FDA product code: PWI — Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K172060
Affected lot / code info: UPN: M0068318250; UDI/DI: 08714729838005; Lot Numbers: 29729168, 29729169, 29972338, 30110291, 30110294, 30254836, 30254837, 30331858, 30338212, 30362314, 30367934, 30434163, 30437947, 30551935, 30598976, 30842709, 30860944, 30993213, 30997334, 31005909, 31257604, 31292169, 31352417, 31367044, 31535491, 31544821, 31554784, 31574100, 31574101, 31624545, 31638194, 31648501, 31727288, 31755722, 31856165, 31856166, 31876917, 31876918, 31876919, 31942747, 31942748, 31984730, 32016719, 32085084, 32259390, 32267863, 32664886, 32699058, 32725350, 32812025, 32842293, 32860360, 32880070, 32988931, 33130079, 33140587, 33530549, 33550168, 33612444, 33753765, 33817740.

Why it was recalled

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

Root cause (FDA determination)

Process change control

Action the firm took

On June 27, 2024 URGENT MEDICAL DEVICE REMOVAL - IMMEDIATE ACTION REQUIRED letters were sent to consignees. Actions to be taken: This removal affects only the products listed in Attachment 1 (Affected Products). No other material numbers or lots are impacted by this removal. Further distribution or use of any remaining product affected by this removal should cease immediately. For Capio SLIM devices that were successfully used in a procedure, no action is needed. Affected worldwide regulatory authorities are being notified of this removal as required. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Patient safety is our highest priority. As such, we are committed to transparent communication to ensure that you have timely, relevant information for managing your patients. If you require additional assistance or more information regarding this communication, please contact your local Boston Scientific representative. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211 and to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone. Online: www.fda.gov/MedWatch/report.htm Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockvi

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Domestic: Nationwide Distribution. International: Pending

Timeline

Recall initiated: 2024-06-27
Posted by FDA: 2024-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.