Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Mo

Is my product affected?

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 ATDRS1

• UPC 00643169882911
• UPC 00763000109059
• UPC 00643169882928
• UPC 00763000109066
• UPC 00643169882935
• UPC 00763000109073

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

What happened

Medtronic Inc. is recalling 9,915 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 model numbers ATDR01, ATDRL1, and ATDRS1 with specific GTINs listed in the recall notice. These pacemakers may experience a circuit error that affects device functionality when programmed to dual chamber mode with atrial-sensing.

The circuit error in these devices could compromise their normal operation. The record does not specify what remedy affected consumers should pursue or what steps they should take in response to this recall.

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: 9915 units Lot/code info: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01, GTIN: 00643169882911, 00763000109059, All Serial Numbers (b) Model Number ATDRL1, GTIN: 00643169882928, 00763000109066, All Serial Numbers (c) Model Number ATDRS1, GTIN: 00643169882935, 00763000109073, 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: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD012019-01-17
• Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL12019-01-17

All FDA (Device enforcement) recalls