Reported Dec 4, 2024 · Ongoing
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the…
Abbott Medical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Abbott Medical · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
- Lot codes and dates
- Model NumberEX1100
- UDI-DI codePending
- Serial Numbers
130 of 130 codes
126002241260030712600895126009741260107412601156126011691260217612602216126024641260249112604265126048521260625412606332126065311260655012606551126065871260678512606814126072891260755712608093126083461260862312608678126087581260881912609094126091481260981912609919126104721261055012611493126117331261197512612409126124171261254112612929126131461261363612617342126173501261758312617821126180541261813012618726126187821261921812619405126195151261982512619827126207451262117112622233
- Amount recalled
- 130 transmitters
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
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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.
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