Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model

Is my product affected?

vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2

• UPC 00643169709331
• UPC 00643169709294
• UPC 00643169709126
• UPC 00643169709140
• UPC 00643169709164
• UPC 00643169709188
• UPC 00643169709249
• UPC 00643169709263
• UPC 00643169883000
• UPC 00643169883017
• UPC 00643169882980
• UPC 00643169882997

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

What happened

Medtronic Inc. is recalling approximately 47,086 dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta, Versa, and Sensia. The affected devices include vitatron implantable pulse generators in A-series (Models A30A1, A60A1), E-series (Models E50A1, E60A1), G-series (Models G70A1, G70A2), and Q-series (Models Q50A2, Q70A2, Q80A2). A subset of these pacemakers may experience a circuit error when programmed to dual chamber mode with atrial-sensing that could affect device functionality.

The recall affects all serial numbers of the specific model numbers and GTINs listed. The source does not specify what remedy consumers should pursue.

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: 47086 units Lot/code info: vitatron (implantable pulse generator): (a) A-series, Model Number: A30A1, GTIN 00643169709331; A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, GTIN 00643169709126, 00643169709140; E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, GTIN 00643169709249, 00643169709263; G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2, GTIN 00643169883017; Q70A2, GTIN 00643169882980; Q80A2, GTIN 00643169882997, All Serial Numbers

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• MEDTRONIC CARELINK 2090 programmer2019-01-17
• 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