CLASS II ONGOING Device recall · Reported 7 Aug 2024 · FDA Enforcement Report
Capio SLIM Suture Capturing Device, Box recalled by Boston Scientific
Boston Scientific is recalling Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner, distributed nationwide in the US. The recall was initiated on 27 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2451-2024
- FDA event ID
- 94921
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jun 2024
- FDA classified
- 30 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 27 Jun 2024 | Recall initiated by company | |
| 30 Jul 2024 | Classified by FDA | +33 days |
| 7 Aug 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Domestic: Nationwide Distribution. International: Pending
Questions about this recall
Is Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner recalled?
Yes. Boston Scientific recalled Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner on 27 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2451-2024.
Why was it recalled?
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Which lots are affected?
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, 30594738, 30597768, 30601523, 30601525, 30608273, 30621482, 30622202, 30628533, 30642670, 30671135, 30825890, 30834186, 30849605, 30853891, 30862718, 30870581, 30877151, 30880729, 31248068, 31305827, 31316815, 31324676, 31400076, 31442842, 31459986, 31475463, 31479225, 31488049, 31494812, 31502318, 31509747, 31514250, 31583783, 31592632, 31600746, 31609045, 31621292, 31764817, 31779852, 31791062, 31809880, 31821132, 31866608, 31876830, 31876835, 31876837, 32040502, 32057254, 32146583, 32163271, 32230325, 32238124, 32351364, 32361264, 32370219, 32385442, 32400087, 32409539, 32418519, 32420869, 32447685, 32456405, 32465857, 32478780, 32499939, 32515625, 32518619, 32526697, 32829992, 32915635, 32979863, 32998255, 33008248, 33017302, 33065907, 33069479, 33216295, 33236632, 33259078, 33283648, 33311001, 33319579, 33375040, 33383769, 33394221, 33404930, 33422407, 33424886, 33454127, 33479450, 33530347, 33556283, 33564420, 33618759, 33670919, 33676308, 33815834
Where was it sold?
Domestic: Nationwide Distribution. International: Pending
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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