Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Styl

FDA device recall Z-0805-2013 · posted 2013-02-12 · Terminated

Recall details

Recalling firm

Aesculap, Inc.

Reason for recall

The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter

Action taken

Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not be returned. Customers with questions should call 610-984-9251 or 610-984-9291. For questions regarding this recall call 1-800-234-9179, ext 5067.

Root cause

Process control

Status

Terminated

Product code

JXG

Quantity affected

11

Distribution

Nationwide Distribution including MI, PA and TX.

Date initiated

2012-06-04

Date posted

2013-02-12

Date terminated

2014-01-08

Location

Center Valley, PA

Related 510(k) clearances