Z-1580-2013 Class I Terminated
FDA device recall Z-1580-2013 was initiated by Medtronic Neuromodulation on Jun 3, 2013 and is designated Class I. Reason for recall: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed… The recall status is terminated (terminated Nov 16, 2015). Affected quantity: 261,109 total devices estimated implanted Worldwide.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2013
- Initiation Date
- Jun 3, 2013
- Termination Date
- Nov 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 261,109 total devices estimated implanted Worldwide
Product Description
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 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 drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids:
Reason for Recall
Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und
Distribution Pattern
worldwide
Code Information
all SynchroMed EL pumps
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1580-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026