Reported Feb 13, 2019 · Terminated
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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 and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
- Lot codes and dates
- UPN Lot Serial #
2,414 of 2,414 codes
00643169763548JVD101565P00643169763548JVD101641P00643169763593JVD102984P00643169763593JVD103032P00643169763593JVD103329P00643169763593JVD103735P00643169763593JVD104028P00643169763593JVD104036P00643169763593JVD104051P00643169763593JVD104100P00643169369030JVD002238P00643169369030JVD002367P00643169369030JVD002630P00643169763593JVD100423P00643169763593JVD100558P00643169763548JVD100793P00643169763548JVD101197P00643169763548JVD101399P00643169763548JVD102238P00643169763548JVD102630P00643169763548JVD102774P00643169763548JVD103626P00643169763548JVD103741P00643169763548JVD103830P00643169763593JVD103921P00643169763593JVD104107P00643169763593JVD104453P00643169763593JVD104483P00643169763593JVD104484P00643169763593JVD104486P
- UPN Lot Serial #
- Amount recalled
- 33007 units
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
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.
This product could cause temporary or reversible health problems — stop using it.
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