The FDA announced that on Jan 17, Medtronic, Inc. has issued a recall for Dual Chamber Implantable Pulse Generators (IPGs) due to a possible circuit error. This has been identified as a Class I recall – the most serious type of recall. Use of these devices may cause serious injuries or death.
Model Names: Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series
Manufacturing Dates: March 2, 2017, to December 18, 2018
Distribution Dates: March 6, 2017, to January 7, 2019
Devices Recalled in the U.S.: 13,440
These units are being recalled due to a possible software error that can result in a lack of pacing, and the occurrence of these errors cannot be predicted by patients and physicians. This lack of pacing could result in slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and death.
Implanting and follow-up physicians should have received a hand-delivered “Field Corrective Action Notification” from Medtronic’s Field Representatives. Patients with such a device should seek immediate medical attention if experiencing new or unexpected symptoms that are consistent with a pause in pacing.
Medtronic’s Technical Services can be reached with any questions at 1-800-505-4636.
Read the original FDA recall announcement for further details.