Z-1622-2018Class II

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

Name: Z-1622-2018 Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ...
Creator: Boston Scientific Corporation
Published: 2018-02-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-02-12 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse on 2018-02-12. FDA classified it as Class II and gives the reason as "Potential for Capio sutures to break and /or detach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1622-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Posted: 2018-05-04
Terminated: 2020-04-10
Recalling firm: Boston Scientific Corporation
Product: Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Product code: PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Reason for recall: Potential for Capio sutures to break and /or detach.
Root cause tag: design
FDA root cause: Device Design
Action: Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.
Quantity in commerce: 24,126
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1622-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1617-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1618-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1619-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1620-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1621-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1622-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1623-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1624-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1625-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1626-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code PWI

K122459Class IIIPinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation / cleared 2012-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)