Recall Z-1557-2022

Reason for recall

Outer carton packaging of microcatheters were exposed to wet substance during transport.

FDA-determined cause: Under Investigation by firm

Action taken

On June 30, 2022, Micro Therapeutics, Inc. issued a "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to affected customers. The recall notification ask consignees to take the following actions: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted product in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3. Complete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information. 4. This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. 5. Adverse reactions or quality problems experienced with this product should be reported to Medtronic and FDA MedWatch Adverse Event Reporting program via: " Medtronic Quality Assurance at rs.nvcomplaints@medtronic.com or call +1 (763) 514-4000 (Worldwide) " The FDA website (http://www.fda.gov/Safety/MedWatch/HowtoReport/default.htm) or call FDA at 1-800-FDA-1088.