Endoscopic Tissue Approximation Device
FDA adverse event reports and recall history for endoscopic tissue approximation device (product code OCW), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 3,154
- Deaths
- 15
- Injuries
- 858
- Malfunctions
- 2,266
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-14Open, ClassifiedUnder Investigation by firm
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- 2026-08-14Open, ClassifiedUnder Investigation by firm
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- 2026-06-01Open, ClassifiedProcess control
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
- 2024-02-06Open, ClassifiedProcess control
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
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