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U.S. Department of Health and Human Services

Class 2 Device Recall CAPIO SLIM

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 Class 2 Device Recall CAPIO SLIMsee related information
Date Initiated by FirmJune 27, 2024
Date PostedJuly 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2452-2024
Recall Event ID 94921
510(K)NumberK172060 
Product Classification Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
ProductCapio 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactRebecca KinKead Rubio
651-895-3653
Manufacturer Reason
for Recall		Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
FDA Determined
Cause 2		Process change control
ActionOn 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
Quantity in Commerce70,890 units total
DistributionDomestic: Nationwide Distribution. International: Pending
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PWI
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