Z-1570-2014 Class II Terminated
FDA device recall Z-1570-2014 was initiated by Medtronic Neuromodulation on Feb 26, 2014 and is designated Class II. Reason for recall: This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also… The recall status is terminated (terminated Sep 28, 2018). Affected quantity: 195,198 pumps (146,435 US, 48,763 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- Feb 26, 2014
- Termination Date
- Sep 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 195,198 pumps (146,435 US, 48,763 OUS)
Product Description
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
Reason for Recall
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re
Distribution Pattern
Worldwide Distribution - All states in USA. OUS: List not provided at this time.
Code Information
This Medical Device Correction notification affects all SynchroMed II pumps.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1570-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026