Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

Is my product affected?

Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

• UPC 00643169529748

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is updating the Instructions for Use and Implant Procedure Tip Card for its Micra MC1VR01 single chamber transcatheter pacing system to include specific information on how to remove the tether that releases the pacemaker from the delivery system during implant. The recall affects 24,521 units distributed worldwide, with specific serial numbers listed in the documentation.

The recall notice does not specify a remedy or action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

Details from the source

Reason for recall: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant. Distribution: Worldwide Quantity: 24521 units Lot/code info: REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610514S MCR610516S MCR610517S MCR610523S MCR610525S MCR610526S MCR610527S MCR610529S MCR610533S MCR610537S MCR610538S MCR610542S MCR610543S MCR610546S MCR610547S MCR610551S MCR610554S MCR610555S MCR610556S MCR610557S MCR610567S MCR610569S MCR610570S MCR610571S MCR610572S MCR610577S MCR610579S MCR610582S MCR610583S MCR610584S MCR610586S MCR610587S MCR610592S MCR610593S MCR610595S MCR610598S MCR610599S MCR610600S MCR610605S MCR610608S MCR610614S MCR610615S MCR610618S MCR610635S MCR610642S MCR610643S MCR610645S MCR610646S MCR610647S MCR610649S MCR610653S MCR610655S MCR610656S MCR610657S MCR610659S MCR610669S MCR610677S MCR610689S MCR610690S MCR610692S MCR610697S MCR610709S MCR610713S MCR610715S MCR610844S MCR610846S MCR610849S MCR610852S MCR610857S MCR610860S MCR610870S MCR610872S MCR610877S MCR610878S MCR610883S MCR610944S MCR610947S MCR610953S MCR610959S MCR610961S MCR610962S MCR610966S MCR610967S MCR610972S MCR610976S MCR610977S MCR610983S MCR610985S MCR610986S MCR610990S MCR610991S MCR610992S MCR610994S MCR610996S MCR610997S MCR610998S MCR611039S MCR611044S MCR611210S MCR611214S MCR611218S MCR611220S MCR611222S MCR611224S MCR611225S MCR611231S MCR611234S MCR611239S MCR611242S MCR611248S MCR611252S MCR611260S MCR611266S MCR611275S MCR611276S MCR611290S MCR611298S MCR611309S MCR611315S MCR611316S MCR611321S MCR611324S MCR611325S MCR611330S MCR611336S MCR611337S MCR6113

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.2019-08-06
• Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing funct2019-08-09
• Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing functio2019-08-09
• Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.2019-08-09
• Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.2019-08-09

All FDA (Device enforcement) recalls