Capio SLIM Suture Capturing Device may fail to catch sutures consistently
Boston Scientific is recalling some lots of Capio SLIM Suture Capturing Devices because they may not consistently catch sutures during surgery, potentially requiring prolonged procedures or additional medical intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a surgical device with a documented functional defect that could lead to complications during surgery. While no injuries or hospitalizations have been reported, the device poses a risk of harm. Per the FDA severity rubric, this qualifies as High (Score 3) for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling approximately 70,890 units of Capio SLIM Suture Capturing Devices distributed nationwide. These devices are used by physicians to facilitate consistent suture placement during open surgical procedures.
The recall affects certain lots of the device that do not consistently catch the suture after activation. This malfunction may result in prolonged surgical procedures or require additional medical interventions.
The affected devices are identified by specific lot numbers and Universal Product Numbers (UPN) listed in the FDA recall notice. Healthcare providers and surgical facilities should verify their device lot numbers and contact Boston Scientific if they have affected units in inventory.
The recalled product
- Product
- Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- suture-capture-failure
- surgical-complication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN: M0068318261 (Pack of 5)
- M0068318260 (Individual Pack)
- UDI/DI: 08714729842224 (Pack of 5)
- 08714729842804 (Individual Pack)
- Lot Numbers: 30110296
- 30110298
- 30254839
- 30269668
- 30277679
- 30340398
- 30348745
- 30361515
- 30369786
- 30477997
- 30485719
- 30502470
- 30509859
- 30566414
- 30571306
- 30579075
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27