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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Ascenda(R) Intrathecal Catheter

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  Class 3 Device Recall Medtronic Ascenda(R) Intrathecal Catheter see related information
Date Initiated by Firm September 21, 2017
Date Posted February 06, 2018
Recall Status1 Terminated 3 on March 20, 2020
Recall Number Z-0537-2018
Recall Event ID 78406
PMA Number P860004 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic Ascenda(R) Intrathecal Catheter, Models:
(a) 8780, UDI: 00643169202122, 00643169783027
(b) 8781, UDI: 00643169202139
(c) 8784, UDI: 00643169202153

The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.
Code Information (a) Model 8780: N740471001, N740482002, N740507001, N741669001, N741918005, N742124002, N742180002, N742214002, N743749002, N747547001, N740471002, N740482003, N740507002, N741669002, N742077001, N742124004, N742180003, N742214003, N743749004, N747547003, N740471003, N740482004, N740507003, N741669003, N742077002, N742124005, N742180004, N742214004, N743749005, N747547004, N740471004, N740482005, N740507004, N741669004, N742077003, N742124006, N742180006, N742214005, N743749006, N747547005, N740471005, N740482006, N740507005, N741669005, N742077004, N742143001, N742184003, N742942001, N743773001, N740471006, N740496001, N740507006, N741669006, N742077005, N742143002, N742184004, N742942002, N743773002, N740476001, N740496003, N740508001, N741677001, N742077006, N742143005, N742184005, N742942003, N743773003, N740476002, N740496004, N740508002, N741677002, N742088001, N742143006, N742184006, N742942004, N743773004, N740476004, N740496005, N740508003, N741677004, N742088002, N742151001, N742197001, N742942005, N743773005, N740476006, N740496006, N740508004, N741677006, N742088003, N742158002, N742197002, N742977001, N743800006, N740477001, N740500001, N740508006, N741688001, N742088004, N742158003, N742197003, N742977002, N744024001, N740477002, N740500003, N740511001, N741688002, N742088005, N742158004, N742197004, N742977003, N744024002, N740477003, N740500004, N740511002, N741688003, N742088006, N742158005, N742197005, N742977004, N744024003, N740477004, N740500005, N740511003, N741688004, N742093002, N742158006, N742197006, N742977005, N744024004, N740477005, N740500006, N740511004, N741688005, N742093004, N742172001, N742211001, N743157002, N744024005, N740477006, N740506001, N740511005, N741688006, N742093005, N742172002, N742211002, N743157003, N744024006, N740479003, N740506002, N740540002, N741918001, N742112003, N742172003, N742211003, N743157004, N747546001, N740479004, N740506003, N740540003, N741918002, N742112004, N742172004, N742211004, N743157005, N747546003, N740479005, N740506004, N740540005, N741918003, N742112006, N742172005, N742211005, N743157006, N747546004, N740482001, N740506006, N740540006, N741918004, N742124001, N742180001, N742214001, N743749001, N747546005   (b) Model 8781: N745579001, N745579002, N745579005, N745579006, N746858001  (c) Model 8784: N745557001, N745557002, N745557003, N745557004, N745557005 
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Justin Ihle
800-707-0933
Manufacturer Reason
for Recall		 There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.
FDA Determined
Cause 2		 Other
Action Medtronic on September 21, 2017, initiated a medical device recall and sent the following via mail (with delivery confirmation) to the consignees. In addition to the mailing, Medtronic field representatives may personally visit the accounts to provide the recall notification, assist the customer as necessary with locating and returning affected product(s), and verify that the customer has or will respond to Medtronic with the Customer Confirmation Form. For further questions, please call (800) 707-0933.
Quantity in Commerce 194 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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