CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump recalled
Medtronic Neuromodulation is recalling Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, distributed nationwide in the US. The recall was initiated on 26 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1570-2014
- FDA event ID
- 67720
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2014
- FDA classified
- 8 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 26 Feb 2014 | Recall initiated by company | |
| 8 May 2014 | Classified by FDA | +71 days |
| 14 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - All states in USA. OUS: List not provided at this time.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
This Medical Device Correction notification affects all SynchroMed II pumps.
Where was it sold?
Worldwide Distribution - All states in USA. OUS: List not provided at this time.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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