Medtronic Recalls Unimplanted SynchroMed II Pumps Due to Motor Stall Risk
Medtronic is recalling unimplanted SynchroMed II Model 8637 pumps to address a design flaw that can cause motor stalls due to corrosion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a motor stall in an implantable drug delivery device, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Medtronic Neuromodulation is recalling the SynchroMed II Model 8637 programmable pump, available in 20 mL and 40 mL reservoir sizes, along with its associated catheter. The recall applies specifically to devices that have not yet been implanted in patients. The company has implemented a final design change intended to address a known issue where motor stalls can occur due to corrosion.
The recall covers 27,547 units distributed in the United States and 13,025 units distributed outside the United States. In the US, the affected devices were distributed nationwide across numerous states, including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Healthcare providers and distributors should identify unimplanted units using the specific Catalogue File Numbers (CFN), Global Trade Item Numbers (GTIN), and Product Identification Numbers (PIN) listed in the official recall notice. Patients who have already had the device implanted are not the target of this specific recall of unimplanted stock, but should consult their healthcare providers for guidance regarding their specific device status and the manufacturer's design changes.
The recalled product
- Product
- Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted in
- Manufacturer
- Medtronic Neuromodulation
- Hazard
Distribution
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