Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01

Is my product affected?

Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01

• UPC 00643169708969
• UPC 00643169708983
• UPC 00643169709072

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

What happened

Medtronic Inc. is recalling approximately 2,040 dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019. The affected devices were sold under the brand names Adapta, Versa, and Sensia, specifically the Versa model number VEDR01. When programmed to a dual chamber mode with atrial-sensing, these pacemakers may experience a circuit error that affects device functionality.

The recall applies to all serial numbers of the affected model. According to the recall record, no specific remedy is listed for consumers who have received this device.

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

Hazard

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

Details from the source

Reason for recall: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality Distribution: Wordlwide Quantity: 2040 units Lot/code info: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

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• MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices2019-01-17
• Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD012019-01-17
• Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS12019-01-17
• Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD012019-01-17

All FDA (Device enforcement) recalls