FDA Device Intelligence
HomeMICROPORT CRM SRL › SMARTVIEW

SMARTVIEW

MICROPORT CRM SRL · Model 2.50 UG1 · UDI-DI 08031527016375

NVZ Prescription
0
510(k) clearances
95,611
Adverse events (3,915 deaths)
40
Recalls
35
Facilities

Recalls

DateFirmReason
2025-06-18Medtronic, Inc.In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a t
2025-06-18Medtronic, Inc.In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a t
2025-04-29Medtronic, Inc.Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficien
2024-10-01Abbott MedicalDue 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 downlo
2024-10-01Abbott MedicalDue 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 downlo
2024-07-11Medtronic Inc.Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by softw
2021-11-08Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR condition
2021-03-15St. Jude Medical, Cardian Rhythm Management DivisionDue to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction
2021-03-15St. Jude Medical, Cardian Rhythm Management DivisionDue to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction
2020-06-04Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.