The Recall Desk
HighFDA (Devices)·Z-1294-2025·Announced 2025-03-12

Tissue Approximation System zip-ties at risk of breaking during implantation

TAS Medical is recalling Tissue Approximation System models because tissue approximation straps (zip-ties) may break before or during surgery. Undetected breaks could lead to hernia recurrence requiring additional corrective surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with a demonstrated manufacturing defect (tissue approximation straps breaking during implantation) but no reported hospitalizations, injuries, or deaths. The consequences—future hernia recurrence and need for corrective surgery—are potential complications not yet documented in reported cases.

Plain-English summary

TAS Medical Inc is recalling 114 units of its Tissue Approximation System (TAS), including models T-4000, T-5000, and T-LAP. The recall addresses a defect in which the tissue approximation straps (zip-ties) may break before or during surgical implantation.

Straps that break during surgery but go undetected during the procedure could remain in the patient's tissue. This could lead to future hernia recurrence or require additional corrective surgery.

The affected devices have been distributed nationwide in Louisiana, Oklahoma, and Tennessee. TAS Medical has developed an interim conditioning method: pre-soaking zip-ties in 104-degree Fahrenheit sterile saline solution for 60 minutes prior to implantation to rehydrate the straps and reduce breakage risk.

Patients or healthcare providers who have received or used these devices should contact TAS Medical or consult their surgeon. Healthcare facilities should apply the interim conditioning protocol to any remaining devices in inventory.

The recalled product

Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Manufacturer
TAS Medical Inc
Category
Medical Device — Surgical / Hernia Repair
Hazard
  • device-failure
  • material-defect
  • surgical-complication

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Model/UDI-DI/Lot(Expiration): T-4000/00197644217267/230403(2024/04/20)
  • T-5000/00860011435921/240801(2025/08/28)
  • 240901(2025/09/25)
  • T-LAP/00860011435914
  • 00197644927241/240702(2025/07/08)
  • 230906(2024/11/29)
  • 230905(2024/11/29)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category