Home › TAS Medical, Inc. › TAS Medical, Inc. Tissue Approximation System

TAS Medical, Inc. Tissue Approximation System

TAS Medical, Inc. · Model T-4000 · UDI-DI 00860011435907

GAR Prescription

510(k) clearances

6,383

Adverse events (2 deaths)

Recalls

115

Facilities

Description

The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.

Recalls

Date	Firm	Reason
2026-06-24	Covidien, LP	Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v
2025-01-27	TAS Medical Inc	Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F steri
2023-12-21	Covidien LP	Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could r
2022-12-02	Covidien, LP	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2022-12-02	Covidien, LP	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2022-12-02	Covidien, LP	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2022-12-02	Covidien, LP	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2016-08-05	Riverpoint Medical, LLC	Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
2016-08-05	Riverpoint Medical, LLC	Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
2014-06-13	Aesculap, Inc.	Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.