Versa recallZ-0811-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Jan 17, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0811-2019
- Status
- Open, Classified
- Initiated by the company
- Jan 17, 2019
- Posted by the FDA
- Feb 14, 2019
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 2040 units
- Product code
- NVZ
- FDA submissions
- P980035
- Distribution
- Wordlwide
Product description
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Code information (models, lots, serial numbers)
Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Versa™ VEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall19 deaths122 reports
- Versa™ VEDR01Medtronic, Inc. · Pulse generator, permanent, implantable1 recall22 deaths98 reports
Product lines
Other devices under the same FDA submission
69 devices cleared under P980035 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)187 deaths7,655 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Adapta™ ADDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)39 deaths1,801 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)41 deaths1,758 reports
- Adapta™ L ADDRL1Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)20 deaths1,072 reports
- Azure™ S DR MRI SureScan™ W3DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)12 deaths715 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)13 deaths654 reports
- Azure™ XT SR MRI SureScan™ W1SR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)22 deaths469 reports
- Azure™ S DR MRI SureScan™ W3DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)2 deaths443 reports
- Sensia™ SEDR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)10 deaths434 reports
- Azure™ XT SR MRI SureScan™ W1SR01Medtronic, Inc. · Pulse generator, permanent, implantable11 deaths425 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 81945).
- Z-0806-2019 · Open, ClassifiedMedtronic 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) Mo…
- Z-0807-2019 · Open, ClassifiedMedtronic 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 …
- Z-0808-2019 · Open, ClassifiedMedtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
- Z-0809-2019 · Open, ClassifiedMedtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
- Z-0810-2019 · Open, ClassifiedMedtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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