# FDA recall Z-0896-2018

> **Medtronic Neuromodulation** · Class II · device recall initiated 2017-08-09.

## 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 infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).

## Reason for recall

Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.

## Distribution

US Nationwide Distribution in the states of 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

## Key facts

- **Recall number:** Z-0896-2018
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-08-09
- **Report date:** 2018-03-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0896-2018

## Citation

> AI Analytics. FDA recall Z-0896-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0896-2018. Source: US FDA. Licensed CC0.

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