TAS Medical recalls Tissue Approximation System models T-4000, T-5000, and T-LAP due to zip-ties breaking during implantation, potentially causing hernia recurrence and needing surgery.
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.
TAS Medical is recalling three surgical systems (T-4000, T-5000, T-LAP) because zip-tie straps can break during implantation. This could lead to hernia recurrence and require additional surgery.
The tissue approximation straps (zip-ties) can break during implantation, which may cause hernia recurrence. This could lead to needing additional surgery to fix a large herniation.
Patients who received the recalled Tissue Approximation System models during surgery are most at risk. The recall applies to specific production lots of these surgical devices.
Check the model number on your device: T-4000, T-5000, or T-LAP. Look for the lot number and expiration date listed in the product description.
Identify your device model (T-4000, T-5000, or T-LAP) and check the lot number against the provided list.
The tissue approximation straps (zip-ties) can break during implantation, potentially causing hernia recurrence and requiring additional surgery.
Check the model number on your device: T-4000, T-5000, or T-LAP. Look for the lot number and expiration date listed in the product description.
The recall does not specify a remedy, so contact your surgeon to discuss next steps.
We’ve drafted a message you can send TAS Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1294-2025 — TAS Medical TAS Medical Hello, I own a TAS Medical that is covered by recall Z-1294-2025 from TAS Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
