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ICLED™ Surgical Suture System
IMPLICIT CARE LLC · Model 70001 · UDI-DI 00861810000303
10
510(k) clearances
20,678
Adverse events (40 deaths)
23
Recalls
248
Facilities
Description
The device designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and elevation of subdermis/underlying muscle procedure. All components are sterile and intended for single use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2019-08-15 | Musculoskeletal Transplant Foundation, Inc. | Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure. |
| 2019-02-21 | ArthroCare Corporation | The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use |
| 2015-04-30 | Smith & Nephew, Inc. | Sterility of device maybe compromised |
| 2014-06-25 | Peters Surgical | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| 2014-06-25 | Peters Surgical | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| 2014-03-11 | Teleflex Medical | The products are being recalled because they did not meet minimum needle attachment strength requirements. |
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Get your free API keyRead the docsData 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.