Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR Sur
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 951 Visia AF MRI implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) distributed nationwide in the United States. These devices may fail to deliver high and low voltage therapy, which are critical functions for treating dangerous heart rhythms. The affected devices include specific product numbers and serial numbers identified by Medtronic.
The recall notice does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Reason for recall: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). Distribution: US Nationwide Distribution. Quantity: 951 devices total Lot/code info: a. Product No. DVFB1D1: UDI 00643169717213 (Serial No. CWG200402H) (EXPANSION: Serial No. CWG200403H, CWG200404H, CWG200406H, CWG200897H, CWG200898H, CWG202225H, CWG202244H, CWG202762H, CWG203250H, CWG203455H, CWG200147H, CWG200899H, CWG202761H); b. Product No. DVFB1D4: UDI 00643169566422 (Serial No. PKX202448H, PKX205417H, PKX205779H, PKX209277H) (EXPANSION: Serial No. PKX211818H, PKX201092H, PKX201561H, PKX201910H, PKX202355H, PKX202386H, PKX202879H, PKX202881H, PKX202882H, PKX202883H, PKX202884H, PKX202885H, PKX202960H, PKX203135H, PKX203209H, PKX203946H, PKX203947H, PKX203950H, PKX204060H, PKX204170H, PKX204372H, PKX204490H, PKX204625H, PKX204629H, PKX204640H, PKX205178H, PKX205179H, PKX205181H, PKX205239H, PKX205240H, PKX205268H, PKX205269H, PKX205659H, PKX205660H, PKX205661H, PKX205662H, PKX205663H, PKX205665H, PKX205666H, PKX205673H, PKX205774H, PKX206142H, PKX206740H, PKX206996H, PKX207013H, PKX207619H, PKX207870H, PKX208254H, PKX209305H, PKX210996H, PKX211165H, PKX211167H, PKX211168H, PKX211169H, PKX211170H, PKX211195H, PKX211196H, PKX211198H, PKX211222H, PKX211223H, PKX211226H, PKX211499H, PKX211847H, PKX211848H, PKX212194H, PKX212195H, PKX212196H, PKX212363H, PKX212763H, PKX212873H, PKX213476H, PKX213477H, PKX213633H, PKX214090H, PKX214355H, PKX214374H, PKX215541H, PKX210995H, PKX210999H, PKX211000H, PKX211029H, PKX211031H, PKX212362H, PKX211654H, PKX212197H), 00643169929913 (Serial No. PKX212710H, PKX213420H); EXPANSION: c. Product No. DVFC3D1: UDI 00643169717206
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.