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A potential for life-threatening blockages has prompted the recall of the Medtronic Infususion Pump. The FDA and Medtronic, Inc. issued a Class I Recall of the Medtronic Infusion Pain Pump, Neuromodulation INDURA IP. This recall includes the following models: intrathecal catheter, the suturless pump, and the intrathecal catheter pump segment revision kit.

Unfortunately, this is a serious recall, since a Class I Recall is the most serious type of product recall issued by the FDA, Food and Drug Administration.  A Class I Recall involves situations where there is a reasonable probability that death or a serious injury will occur from using the product. 

How are the recalled Products used?
The intrathecal catheter revision kits or the intrathecal catheter use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter  is a part of an infusion system. The catheter delivers and stores drugs into a specific space. 

What promoted the Recall?
The recall of the Medtronic Infusion Pump was due to the potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. Reports have shown these misconnections to have caused a blockage between, the catheter port on the pump, disconnection from the pump connector and the sutureless pump connector.

The following product models are included in the Recall:
Sutureless Pump; Connector Revision Kit, Model 8678; 
Intrathecal Catheter, Model 8731SC; 
Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC
Intrathecal Catheter, Model 8709SC

It is important to note that this recent recall does not include the MiniMed infusion pumps made by Medtronic.

What should you do if you have a Pain Pump?
If you or a loved one have used a Pain Pump since January 22, 2007, contact your physician to ask questions. You can also contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. Central Daylight Time. 

Click here to read FDA Recall of Medtronic Pain Pump.

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There has been a Class 1 Recall for Product: Fire Star™ RX and Dura Star™ RX PTCA Balloon Catheters manufactured by the Florida based Cordis Corporation. The concerned products were manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star™ RX was distributed in the U.S. on August 29, 2007 and Fire Star™ RX was distributed in the U.S. on August 31, 2007.

All Fire Star™ and Dura Star™ lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).

The Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. 

The product was found to have a potential slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death. 

Since Class 1 recalls are serious recalls that involve situations in where there is a reasonable probability that use of the product will cause serious injury or death.

If you are a consumer or Health care professional and find adverse reactions or quality problems experienced with the use of this product, please contact the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online:www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

FAX: 1-800-FDA-0178

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