CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Uphold Lite w/ Capio Slim recalled by Boston Scientific

Boston Scientific is recalling Uphold Lite w/ Capio Slim, distributed in Georgia. The recall was initiated on 12 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:08714729839200 Batch numbers: 27019 56827 21250249 27898 56829 21271669 28713 57715 21336724 28974 57716 21377535 29299 58081 21402115 30503 58083 21432026 31359 58944 21447170 31516 58945 21496403 32828 60407 ML00002769 32829 60409 ML00002810 33791 61098 ML00002857 33792 61420 ML00002913 34053 61421 ML00002964 36070 61422 ML00002999 37918 61425 ML00003034 39009 61426 ML00003091 39700 62156 ML00003142

Quantity recalled24,126

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-1622-2018
FDA event ID: 79608
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 12 Feb 2018
FDA classified: 4 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Feb 2018	Recall initiated by company
4 May 2018	Classified by FDA	+81 days
16 May 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for Capio sutures to break and /or detach.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Where it was distributed

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

Georgia

Questions about this recall

Is Uphold Lite w/ Capio Slim recalled?

Yes. Boston Scientific recalled Uphold Lite w/ Capio Slim on 12 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1622-2018.

Why was it recalled?

Potential for Capio sutures to break and /or detach.

Which lots are affected?

UDI:08714729839200 Batch numbers: 27019 56827 21250249 27898 56829 21271669 28713 57715 21336724 28974 57716 21377535 29299 58081 21402115 30503 58083 21432026 31359 58944 21447170 31516 58945 21496403 32828 60407 ML00002769 32829 60409 ML00002810 33791 61098 ML00002857 33792 61420 ML00002913 34053 61421 ML00002964 36070 61422 ML00002999 37918 61425 ML00003034 39009 61426 ML00003091 39700 62156 ML00003142

Where was it sold?

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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