Z-0810-2019 Class I Ongoing
FDA device recall Z-0810-2019 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on January 17, 2019 and is designated Class I. 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 wit… The recall status is ongoing. Affected quantity: 5392 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- January 17, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5392 units
Product Description
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
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 Pattern
Wordlwide
Code Information
Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers