CLASS I Device recall · Reported 19 Dec 2012 · FDA Enforcement Report

Medtronic SynchroMed II recalled by Medtronic Neuromodulation

Medtronic Neuromodulation is recalling Medtronic SynchroMed II, distributed nationwide in the US. The recall was initiated on 9 Nov 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll SynchroMed EL and SynchroMed II pumps

Quantity recalled174,700 devices total

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-0497-2013
FDA event ID: 63712
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class I
Status: Terminated
Recall initiated: 9 Nov 2012
FDA classified: 13 Dec 2012
Reported: 19 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Hidden Drug Ingredients
Device type: Heart & Vascular Devices

Timeline

9 Nov 2012	Recall initiated by company
13 Dec 2012	Classified by FDA	+34 days
19 Dec 2012	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

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.

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.

Nationwide

Questions about this recall

Is Medtronic SynchroMed II recalled?

Yes. Medtronic Neuromodulation recalled Medtronic SynchroMed II on 9 Nov 2012. The recall is Class I and its status is Terminated. Recall number Z-0497-2013.

Why was it recalled?

Which lots are affected?

All SynchroMed EL and SynchroMed II pumps

Where was it sold?

Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 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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