Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169

FDA device recall Z-0537-2018 · posted 2018-02-06 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LKK

Quantity affected

194 units

Distribution

Nationwide Distribution

Date initiated

2017-09-21

Date posted

2018-02-06

Date terminated

2020-03-20

Location

Minneapolis, MN