Medtronic Neuromodulation IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container.
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
Lot 60538731, Use by Date is May 10, 2009.
Products Sold
Lot 60538731, Use by Date is May 10, 2009.
Medtronic Neuromodulation is recalling IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMe due to Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death.
Recommended Action
Per FDA guidance
Consignees were notified by Medtronic field personnel, either by personal visits or telephone, beginning 2/4/08. This included the 8 additional consignees located outside of the U.S. Medtronic advised customers not to use any unused packages in their inventory and that a field representative would assist them in returning the product for replacement and/or credit. Upon completion of each follow-up, the field representatives completed and returned a Reply Card documenting the notification. If you have questions or comments, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CT, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MI, MS, MO, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026