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WECK

TELEFLEX INCORPORATED · Model IPN002709 · UDI-DI 04026704558834

OCW Prescription
1
510(k) clearances
3,206
Adverse events (15 deaths)
4
Recalls
57
Facilities

Description

WECK ENDO FASCIAL CLOSURE SYSTEM

Recalls

DateFirmReason
2026-07-14Boston Scientific CorporationDevice may fail to deploy the cinch implant and/or fail to cut the suture as intended.
2026-07-14Boston Scientific CorporationDevice may fail to deploy the cinch implant and/or fail to cut the suture as intended.
2026-04-15Covidien, LPThe presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
2023-11-16Covidien LPPackaging 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 steril

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.