Recall record at a glance
| Official record | Z-2352-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medtronic Neuromodulation |
| Report date | Jul 24, 2024 |
| Recall initiation date | May 10, 2024 |
| Quantity | 111762 units |
| Location | Minneapolis, MN, United States |
Official product description
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Why the product was recalled
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
Distribution information
Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Iran, Islamic Republic, Iraq, Ireland, Jordan, Kazakhstan, Korean Republic of, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherland, New Zealand, Norway, Oman, Panama, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirate, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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