FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36m

FDA device recall Z-1304-2014 · posted 2014-03-27 · Terminated

Recall details

Recalling firm

Medtronic Vascular, Inc.

Reason for recall

Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

Action taken

Medtronic sent an Urgent Device Recall letter dated March 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records show that your facility has received one or more of these FIBERNET EPS, as shown in the attachment to this notification. Consequently, Medtronic requests you immediately take the following actions: 1. Immediately remove and quarantine all potentially affected product that remains in your inventory. 2. Return these units to Medtronic. Contact Customer Service at 1-888- 283-7868 and reference RADAR # 174028 to initiate a return and credit of product. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com, or fax 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 the potentially affected product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. lf any FIBERNET EPS 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 apologize for the inconvenience this may cause you; please be assured that patient safety and product quality remain our primary concern. Should you have any questions, please contact your Medtronic representative or Medtronic LifeLine Technical Services at 1 (877) 526-7890 or (+1 763) 526-7890.

Root cause

Manufacturing material removal

Status

Terminated

Product code

NTE

Quantity affected

50 Total all sizes: 18 in US, 32 Internationally.

Distribution

Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.

Date initiated

2014-03-03

Date posted

2014-03-27

Date terminated

2014-06-03

Location

Santa Rosa, CA

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