Z-2452-2024Class II

Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by...

Name: Z-2452-2024 Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by...
Creator: Boston Scientific Corporation
Published: 2024-06-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-06-27 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement... on 2024-06-27. FDA classified it as Class II and gives the reason as "Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2452-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-27
Posted: 2024-07-30
Recalling firm: Boston Scientific Corporation
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.
Product code: PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
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 root cause: Process change control
Action: 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
Quantity in commerce: 70,890 units total
Distribution: Domestic: Nationwide Distribution. International: Pending
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2452-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2451-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-30
Z-2452-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-30

Product code PWI

K172060Class IICapio SLIM Suture Capturing DeviceBoston Scientific Corporation / cleared 2017-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)