FDA recall Z-2452-2024

Boston Scientific Corporation · Class II · device

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.

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.

Distribution

Domestic: Nationwide Distribution. International: Pending

Key facts

Status
Ongoing
Initiation date
2024-06-27
Report date
2024-08-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2452-2024