Recall Z-2331-2024 ยท GWG Endoscope, Neurological
Integra LifeSciences Corp.
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
| Date | Jul 11, 2024 (initiated Jun 7, 2024) |
| Status | Open, Classified |
| Reason | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. |
| Root cause | Process change control |
| Action | A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter, dated 6/7/24, was mailed to consignees. The notification instructs consignees to immediately remove any affected devices from service and place them in quarantine. The recall notification is to be forwarded to users of the product within your facility for their awareness. Consignees are to complete the provided response form and return it via email to FCA3@integralife.com or by fax to 1-609-750-4220. Integra Customer Service will reach out to consignees regarding a Return Materials Authorization and return directions upon r |
| Quantity | 14 units |
| Distribution | Domestic: NY, OH, & DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232618 | Aurora Surgiscope System Rebound Therapeutics Corporation, Oct 27, 2023 |