Tissue Approximation System (Tas) recallZ-1294-2025 · TAS Medical Inc · initiated Jan 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TAS Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.
FDA root cause category: Device Design
What the company is doing
On 1/27/2025, correction notices were emailed to customers who were asked to do the following: 1) Firm has developed and validated an interim method for conditioning the product in the surgical suite just prior to implantation to rehydrate the zip-tie straps per these instructions. To reverse the effects of dehydration, when preparing for surgery, submerge the TAS zip-tie straps in 40-degreesC (104-degrees F) sterile saline solution for 60 minutes prior to implantation. The orange leader material is not subject to dehydration and therefore is not required to be soaked. 2) Quarantine affected devices and insert the rehydration procedure into each of the remaining product boxes in your inventory at which point it can be released from quarantine. 3) Firm is is in the process of redesigning its packaging to prevent dehydration of the straps and will let you know when the new packaging is available. We anticipate that it may take up to six months to redesign the packaging, validate it, and release it to the field. Until then, the above rehydration procedure will restore the hydration to the straps in the surgical suite thereby preventing breakage that has been seen in the field. 4) Complete and return the acknowledgement and receipt form via email to [email protected] Questions can be directed to the firm at (716) 997-2896 Monday through Friday between the hours of 8am and 5pm, EST.
Recall details
- Recall number
- Z-1294-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 27, 2025
- Posted by the FDA
- Mar 6, 2025
- Recalling firm
- TAS Medical Inc
- Quantity
- 114
- Product code
- GAR
- FDA submissions
- K220980
- Distribution
- US Nationwide distribution in the states of LA, OK, TN.
Product description
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Code information (models, lots, serial numbers)
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)
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- TAS Medical, Inc. Tissue Approximation System T-4000TAS Medical, Inc. · Suture, Nonabsorbable, Synthetic, Polyamide1 recall0 reports
- TAS Medical, Inc. Tissue Approximation System T-LAPTAS Medical, Inc. · Suture, Nonabsorbable, Synthetic, Polyamide1 recall0 reports
- TAS Medical, Inc. Tissue Approximation System T-LAPTAS Medical, Inc. · Suture, Nonabsorbable, Synthetic, Polyamide1 recall0 reports
- TAS Medical, Inc. Tissue Approximation System T-5000TAS Medical, Inc. · Suture, Nonabsorbable, Synthetic, Polyamide1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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