Severity
Critical
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Reported: December 19, 2012 Initiated: November 9, 2012 #Z-0497-2013 174,700 devices total units
Medtronic Neuromodulation issued this FDA Devices recall on December 19, 2012. Classified as Critical severity (Class I). Approximately 174,700 devices total units are affected. The recall was issued because: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infu…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0497-2013) was formally reported on December 19, 2012, with the manufacturer initiating the action on November 9, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Medtronic Neuromodulation is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 174,700 devices total units are affected, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of … Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
174,700 devices total
Related Recalls
6
6 from same agency
Product Description
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Reason for Recall
Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 174,700 devices total
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
- Location
- Minneapolis, MN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0497-2013 |
| Date reported | December 19, 2012 |
| Date initiated | November 9, 2012 |
| Recalling firm | Medtronic Neuromodulation |
| Units affected | 174,700 devices total |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.. Recalled by Medtronic Neuromodulation. Units affected: 174,700 devices total.
Why was this product recalled? ▼
Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2012. Severity: Critical. Recall number: Z-0497-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0497-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).