Generic Name: Intraspinal Catheter — Brand Name: Ascenda Catheter
Recall Summary Medtronic is recalling unused Ascenda Catheters (intraspinal catheters) manufactured before May 9, 2024, because tissue can enter the pump connector and cause the catheter to become blocked. Catheters that have already been implanted in patients do not require removal, as blockage occurs rarely enough that patient monitoring is considered sufficient. The company redesigned the product and has decided to recall the older stock now that new inventory is available.
- Recalling firm
- Name of Manufacturer and Distributor: Medtronic Japan Co., Ltd. — Address of Manufacturer and Distributor: 1-2-70 Konan, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer and...
- Product
- Lot: モデル番号：8781 ・2024年5月9日以前に製造された未使用製品のロット番号（数量33個）： HG7VU4Y16 HG7VU4Y15 HG7VU4Y07 HG7VU4Y06 HG7VU4Y05 HG7VU4Y04 HG7UQLM10 HG7UQLM09 HG7UQLM06 HG7UQLM04 HG7UQ9A02 HG7UM1V16 HG7UM1V15 HG7UM1V09 HG7UM1V01 HG7U3KD16 HG7NW2805 HG7NVZD13 HG7NVAT04 HG7NS7D07 HG7NS7D01 HG7NS3P05 HG7NRVM14 HG7NRVM12 HG7NPJ417 HG7NPJ416 HG7NPJ414 HG7NPJ404 HG7LVNH13 HG7LVNH05 HG7FPBC07 HG7DTP007 HG6ZLNC13 ・2024年5月9日以前に製造された使用期限切れまたは使用済みのロット番号（数量2344個）： N798912001 N798911006 N798911005 N798911004 N798911003 N798911002 N798911001 N798905006 N798905005 N798905004 N798905003 N798905002 N798905001 N798869005 N798869004...
- Reason
- Since July 2024, we have been providing updates regarding the occurrence of tissue entering the pump connector of the Ascenda catheter and the design modification of the Ascenda catheter. The purpose of this design modification is to reduce the risk of catheter occlusion caused by this issue. We have now decided to voluntarily recall unused Ascenda catheters manufactured prior to the design change, as the manufacturer has secured sufficient inventory of the redesigned product. Please note that for products already implanted, no intervention such as replacement surgery is necessary, as the...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/c352bd46-d5ff-43df-8d30-ae98c4f765dd