Boston Scientific Capio SLIM Device May Fail During Surgical Procedures
Some lots of the Capio SLIM suture capturing device may fail to consistently catch sutures during surgery, potentially requiring extended 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 an FDA Class II recall with no reported hospitalizations, injuries, or deaths. The device may fail to perform its intended function during surgery, potentially prolonging the procedure or requiring additional intervention, but no actual adverse events are documented. Per the rubric, a Class II recall without reported harm and with only theoretical risk is scored as High (3).
Plain-English summary
Boston Scientific Corporation is recalling certain lots of the Capio SLIM Suture Capturing Device, used by surgeons to place sutures during open surgical procedures. The affected lots may not consistently catch the suture after activation.
When the device fails to catch the suture as designed, the surgical procedure may take longer or require additional medical intervention to complete the suturing.
The recall affects 70,890 units distributed nationwide. Affected lot numbers are listed with the FDA. Healthcare facilities and surgical centers should verify their inventory against the recall lot numbers and follow the FDA recall notice for guidance.
The recalled product
- 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.
- 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: M0068318250
- UDI/DI: 08714729838005
- Lot Numbers: 29729168
- 29729169
- 29972338
- 30110291
- 30110294
- 30254836
- 30254837
- 30331858
- 30338212
- 30362314
- 30367934
- 30434163
- 30437947
- 30551935
- 30598976
- 30842709
- 30860944
- 30993213
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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