Recall record at a glance
| Official record | Z-0845-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Report date | Feb 27, 2019 |
| Recall initiation date | Jan 17, 2019 |
| Quantity | 731 units |
| Location | Mounds View, MN, United States |
Official product description
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Why the product was recalled
There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.
Distribution information
US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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