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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 70,890
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.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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