Integra LifeSciences recalls Bactiseal Endoscopic Ventricular Catheters (823087) that were mislabeled as Bactiseal Shunt Systems (823073). This could lead to incorrect use in hydrocephalus treatment.
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Integra LifeSciences is recalling Bactiseal Endoscopic Ventricular Catheters (model 823087) that were mislabeled as Bactiseal Shunt Systems (model 823073). This mislabeling could cause incorrect medical use in hydrocephalus treatment.
Mislabeled products could be used incorrectly in hydrocephalus treatment. The Bactiseal Endoscopic Ventricular Catheter (823087) is designed for specific brain fluid drainage procedures, but being labeled as the Shunt System (823073) might lead to improper use.
Patients using hydrocephalus shunt systems who own the Bactiseal Endoscopic Ventricular Catheter (823087) or Bactiseal Shunt System (823073) are most at risk. The recall affects medical devices used in brain fluid drainage procedures.
Check for part number 823087 on the catheter or lot number 4178257 with expiration date November 2019. The product was sold for hydrocephalus treatment with cerebrospinal fluid shunting.
Look for part number 823087 on the catheter or lot number 4178257 with expiration date November 2019.
Bactiseal Endoscopic Ventricular Catheter (part number 823087) that was mislabeled as Bactiseal Shunt System (part number 823073).
Mislabeled products could be used incorrectly in hydrocephalus treatment, potentially leading to improper cerebrospinal fluid drainage.
Check the product label for part number 823087 or lot number 4178257 with expiration date November 2019. If mislabeled, contact Integra LifeSciences for guidance.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0725-2021 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0725-2021 from Integra LifeSciences. 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.
