Has TISSIUM SA had other FDA enforcement actions?

Yes. Argus HQ has recorded 8 total FDA actions tied to TISSIUM SA: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

TISSIUM SA — Class II recall: Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Numb…

Name: FDA Recall Record — TISSIUM SA
Creator: Argus HQ
Published: 2026-08-12
License: https://argushq.ai/methodology

Event date: 2026-08-12 00:00:00Z
Observed: 2026-08-19 04:20:45Z
Source ID: Z-2902-2026
Payload hash: f311693b4a02330378a173b3…

Summary

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case… Status: Ongoing.

Entities

TISSIUM SA

View source record ↗

Frequently asked questions

Has TISSIUM SA had other FDA enforcement actions?: Yes. Argus HQ has recorded 8 total FDA actions tied to TISSIUM SA: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). TISSIUM SA — Class II recall: Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Numb…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-tissium-sa-z-2902-2026

MLA

"TISSIUM SA — Class II recall: Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Numb…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-tissium-sa-z-2902-2026.

Chicago

Argus HQ Research. "TISSIUM SA — Class II recall: Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Numb…." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-tissium-sa-z-2902-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_tissium_sa_z_2902_2026_2026,
  title = {TISSIUM SA — Class II recall: Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Numb…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-tissium-sa-z-2902-2026},
  note = {Accessed: August 19, 2026}
}

Informational only. Not legal, financial, or medical advice.