Recall Z-0806-2019
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated January 17, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
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 ADVDD01
Codes / lots: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01, GTIN: 00643169708754, All Serial Numbers (b) Model Number ADDR01, GTIN: 00643169708587, 00643169708594, 00643169708600, 0643169708624, 00643169969711, All Serial Numbers (c) Model Number ADDR03, GTIN: 00643169708631, 00643169708648, All Serial Numbers (d) Model Number ADDR06, GTIN: 00643169708655, 00643169708662, All Serial Numbers (e) Model Number ADDRL1, GTIN: 00643169518247, 00643169708679, 00643169708686, 00643169708709, 00643169969803, All Serial Numbers (f) Model Number ADDRS1, GTIN: 00643169708716, 00643169708723, 00643169708730, 00643169708747, 00643169969810, All Serial Numbers (g) Model Number ADVDD01, GTIN: 00643169708761, 00643169708778, 00643169969735, All Serial Numbers
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
FDA-determined cause: Component design/selection
Action taken
In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand deliver an FCA Notification Letter to consignees including implanting and follow-up physicians. In consultation with an Independent Physician Quality Panel (IPQP), patient management recommendations were provided with the FCA Notification letter to ensure patient safety. Medtronic Field Representatives will hand deliver an additional Supplemental Letter with the Urgent Medical Device Recall letter to a subset of physicians with patients whose device has shown evidence of a pacing pause that is potentially related to this circuit error. Consignees will be asked to return all unused and unopened affected product to Medtronic.
Details
- Recall number
- Z-0806-2019
- Initiated
- January 17, 2019
- Posted by FDA
- February 14, 2019
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 41802 units
- Distribution
- Wordlwide
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0807-2019 Class I | Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | 01/17/2019Open, Classified |
| Z-0808-2019 Class I | Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | 01/17/2019Open, Classified |
| Z-0809-2019 Class I | Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | 01/17/2019Open, Classified |
| Z-0810-2019 Class I | Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | 01/17/2019Open, Classified |
| Z-0811-2019 Class I | Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | 01/17/2019Open, Classified |
| Z-0812-2019 Class I | vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b)…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | 01/17/2019Open, Classified |