NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, In

FDA device recall Z-2302-2013 · posted 2013-09-30 · Terminated

Recall details

Recalling firm

Medtronic Vascular, Inc.

Reason for recall

Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.

Action taken

Medtronic sent an Urgent Medical Device Recall letter beginning September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received affected NC Sprinter RX Balloon Dilatation Catheters as noted in the attached customer notification detail report. Consequently, Medtronic is asking you to take the following actions: 1. Remove and quarantine all affected catheters that remain in your inventory. 2. Return the affected catheters to Medtronic. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Medtronic has taken the necessary steps to prevent any future shipment of mislabeled product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. If any NC Sprinter RX Balloon Dilatation Catheters within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product. We appreciate your cooperation and apologize for the inconvenience that this issue may cause. Should you have any questions, please contact your local Medtronic representative.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

LOX

Quantity affected

122

Distribution

Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.

Date initiated

2013-09-16

Date posted

2013-09-30

Date terminated

2014-02-10

Location

Santa Rosa, CA