FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 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
- Recall number
- Z-0806-2019
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- 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
- Status
- Open, Classified
- Initiated
- 2019-01-17
- Posted
- 2019-02-14
- Terminated
- not on file
- Reason
- 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
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 41802 units
- Distribution
- Wordlwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P980035"]
- Product code
- NVZ
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28