Reported Jul 3, 2013 · Terminated
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO.…
Medtronic Inc. Cardiac Rhythm Disease Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. Cardiac Rhythm Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
- Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
- Lot codes and dates
- UPDATED 7/18/2013Serial
- Numbers
1,128 of 1,128 codes
PVX610233SPVX610234SPVX610253SPVX610258SPVX610296SPVX610302SPVX610308SPVX610311SPVX610312SPVX610313SPVX610314SPVX610315SPVX610317SPVX610318SPVX610319SPVX610320SPVX610321SPVX610323SPVX610324SPVX610325SPVX610326SPVX610328SPVX610329SPVX610331SPVX610332SPVX610334SPVX610335SPVX610337SPVX610338SPVX610339SPVX610340SPVX610341SPVX610342SPVX610343SPVX610344SPVX610346SPVX610347SPVX610348SPVX610350SPVX610352SPVX610353SPVX610355SPVX610358SPVX610360SPVX610361SPVX610364SPVX610366SPVX610367SPVX610368SPVX610371SPVX610372SPVX610373SPVX610374SPVX610375SPVX610376SPVX610377SPVX610378SPVX610379SPVX610380SPVX610381S
- Amount recalled
- 1912 (159 USA & 1137 OUS) UPDATED: 1128 affected
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc. Cardiac Rhythm Disease Management recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.