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Class I recall for Medtronic infusion pumps

This article was originally published in The Silver Sheet

Executive Summary

FDA has labeled as Class I a recall involving an intrathecal catheter connection problem in Medtronic's SynchroMed and IsoMed implantable infusion pump systems. Announced Sept. 26, the action covers four models of Indura One-Piece sutureless connector intrathecal catheters used with the pumps. More than 25,000 of the catheters have been sold in the United States, according to the company. The occlusions or disconnections can result in a "clinically significant or fatal drug overdose," drug withdrawal symptoms, lack of therapeutic effect or a return of underlying symptoms, the firm explains. In a June safety alert describing the problem before it was classified as a recall, Medtronic said that patients with misaligned or disconnected catheters will require corrective surgery. Previously, SynchroMed systems were the subject of an August 2007 recall due to pump gear shaft wear and a January 2008 recall citing the risk of inflammatory masses around catheter tips
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