Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 with defective sterile seal that may compromise safety during surgery.
Due to a defect in the outer pouch sterile seal
Medtronic is recalling a specific laser surgical device due to a defect in its outer pouch sterile seal. This could potentially compromise the device's safety during medical procedures.
The defect in the outer pouch sterile seal could compromise the device's safety during surgical procedures. This might lead to contamination or infection risks if the seal fails during use.
Physicians using this specific surgical device for minimally invasive procedures are affected. Patients undergoing surgery with this device may be at risk.
Check for product number 9735560 with lot numbers 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, or 0224824769. This device is used for necrotizing or coagulating soft tissue during surgery.
Verify your device has product number 9735560 and one of the listed lot numbers.
The outer pouch sterile seal has a defect that could compromise safety during surgical procedures.
Check for product number 9735560 with lot numbers 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, or 0224824769.
The recall record does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0244-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0244-2023 from Medtronic. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
