Medical Devices

Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes: Switching Tubes May Cause Breathing Issues

Recall Class: Class I

Date Recall Initiated: May 8, 2015

Devices:
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube
Cuffless Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff

Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes

Use: A tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). The Shiley tracheostomy tubes are single-use devices placed into the surgical opening of the trachea to provide an airway and to remove secretions from the lungs. The patient populations for these devices include infants and children.

Recalling Firm:

Medtronic Navigation, Inc.
60 Middletown Avenue
North Haven, Connecticut 06473

Reason for Recall: Medtronic received reports that tracheostomy patients whose tubes were switched from a previous Shiley tracheostomy tubes to the newer model tubes experienced airway obstruction because of potential differences in the angle of the newer tubes from that of the older tubes. Since each patient has their own distinct anatomy and their trachea may have become accustomed to the inserted tube, changing the tube, particularly to one with a different angle, may cause airway obstruction.

Airway obstruction may cause acute lack of oxygen in the blood (oxygen desaturation), low amounts of oxygen reaching body tissue (hypoxia), and excessive carbon dioxide in the patient’s blood (hypercapnia). Breathing difficulties associated with these issues were observed immediately after switching patients from the older tubes to the newer tubes. If left untreated, these events may result in permanent injury.

Twelve reports of serious injuries have been reported to the FDA; no deaths have been reported.

Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead.

Public Contact: For questions regarding the RGA / return process, please contact Medtronic at ShileyFCA@Covidien.com or 800.635.5267 option 1, option 1, and again option 1.

FDA District: Denver District Office

More Information about this Recall:

Medtronic notified customers of the recall in a May 8, 2015 letter.

The letter included the following instructions:

REQUIRED ACTIONS FOR CUSTOMERS:

  1. Quarantine and discontinue use of the affected devices.
  2. Return affected product using the instructions below:

Customers who purchased the tubes directly from Medtronic:
Complete the Shiley™ Tracheostomy Tube Recalled Product Return Form and fax it to (925) 463-4600 or email it to ShileyFCA@covidien.com.

If you have affected units to return, Medtronic technical service will respond with a Return Goods Authorization (RGA) number and shipping documents to cover shipment pickup and freight costs associated with the return of the product. Once the RGA number is received, enter this number on your original form and include the form with your returned product.

Ship affected product(s) with the RGA number provided to:

Medtronic
Attn: RGA
2824 Airwest Blvd
Plainfield, IN 46168

The company requests that customers reply to Medtronic whether or not they have affected products at their facility. If you do not have any units to return, return the form indicating you have zero units.

Customers who purchased the tubes from a distributor:
Complete the Recalled Product Return Form and contact your distributor directly for directions on returning the product. The completed form should be emailed to the following address: ShileyFCA@Covidien.com or faxed to (203)-492-7719.

All affected product must be returned through the Distributor with a copy of the completed form.

About Class I Recalls

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Affected Product Numbers and Lot:

The recall is limited to the product codes and associated lot numbers listed in the table below. If you are unable to determine the lot number of any of the product codes and size listed in the table, then those products should be treated as if they are within the affected lot numbers and you should proceed as directed. Lot numbers will appear on the product labeling and the number is structured with the first two digits representing the year of manufacturing, i.e., 12 is for 2012, 13 is for 2013 and 14 is for 2014.

Cuffless Products

Product Description Name

Product Numbers

Lot

Shiley Neonatal Tracheostomy Tube Cuffless

2.5NEF

All lot numbers beginning with 12, 13 and 14

3.0NEF

3.5NEF

4.0NEF

4.5NEF

Shiley Pediatric Tracheostomy Tube Cuffless

2.5PEF

All lot numbers beginning with 12, 13 and 14

3.0PEF

3.5PEF

4.0PEF

4.5PEF

5.0PEF

5.5PEF

Shiley Pediatric Tracheostomy Tube Long Cuffless

5.0PELF

All lot numbers beginning with 12, 13 and 14

5.5PELF

6.0PELF

6.5PELF

 

Cuffed Products

Product Description Name

Product Numbers

Lot

Shiley Neonatal Tracheostomy Tube with TaperGuard™ Cuff

2.5NCF

All lot numbers beginning with 12, 13 and 14

3.0NCF

All lot numbers beginning with 12, 13 and 14; and Lot number 15A0152JZX

3.5NCF

All lot numbers beginning with 12, 13 and 14; and Lot number 15A0154JZX

4.0NCF

All lot numbers beginning with 12, 13 and 14

4.5NCF

All lot numbers beginning with 12, 13 and 14; and Lot number 15A0155JZX

Shiley Pediatric Tracheostomy Tube with TaperGuard™ Cuff

2.5PCF

All lot numbers beginning with 12, 13 and 14; and Lot number 15A0153JZX

3.0PCF

All lot numbers beginning with 12,13 and 14;  and Lot number 15A0151JZX

3.5PCF

 

All lot numbers beginning with 12, 13 and 14

4.0PCF

4.5PCF

5.0PCF

5.5PCF

Shiley Pediatric Tracheostomy Tube Long with TaperGuard™ Cuff

5.0PLCF

 

All lot numbers beginning with 12, 13 and 14

5.5PLCF

6.0PLCF

6.5PLCF

 

Disposable Bedside Tray (Tray contains 4 units)

Product Description Name

Product Numbers

Lot

Shiley Neonatal Tracheostomy Tube Cuffless, Disposable Bedside Tray

3.0NEF-P

All lot numbers beginning with 12, 13 and 14

3.5NEF-P

4.0NEF-P

4.5NEF-P

Pediatric Tracheostomy Tube Cuffless, Disposable Bedside Tray

3.0PEF-P

All lot numbers beginning with 12, 13 and 14

3.5PEF-P

4.0PEF-P

4.5PEF-P

5.0PEF-P

5.5PEF-P

 

Page Last Updated: 07/22/2015
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