Lower risk Medical device recall · FDA · Published January 17, 2019

Medtronic Dual Chamber Pacemakers: Circuit Error Risk in Specific Models

Medtronic recalls specific dual chamber pacemaker models (RED01, REDR01, REVDD01) distributed 2017-2019 that may experience circuit errors affecting device function. Owners should contact Medtronic for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0808-2019Medical device Medtronic ›

Lower-risk 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

Take action

Contact the company

Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain dual chamber pacemakers (RED01, REDR01, REVDD01) made between March 2017 and January 2019. These devices may have circuit errors that affect their function if programmed for dual chamber mode with atrial sensing. Read more at govinfonow.com/recall/69097-medtronic-dual-chamber-pacemakers-circuit-error-risk-in-specific-models.

Source Summary by GovInfoNow · govinfonow.com/recall/69097-medtronic-dual-chamber-pacemakers-circuit-error-risk-in-specific-models · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0808-2019

Cite this page

“Medtronic Dual Chamber Pacemakers: Circuit Error Risk in Specific Models.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/69097-medtronic-dual-chamber-pacemakers-circuit-error-risk-in-specific-models. Based on FDA recall #Z-0808-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0808-2019%22&limit=1).

The FDA announced on Jan. 17, 2019, that Medtronic Inc. is recalling dual chamber pacemakers due to a circuit error affecting device functionality. The agency issued the voluntary Class I recall under number Z-0808-2019.

How to tell if you have it

Medtronic RELIA Dual chamber pacemaker (VDD), Model Number RED01
Medtronic RELIA Dual chamber pacemaker (VDD), Model Number REDR01
Medtronic RELIA Dual chamber pacemaker (VDD), Model Number REVDD01

The hazard

A subset of Medtronic dual chamber pacemakers distributed worldwide between March 10, 2017, and Jan. 7, 2019, may experience a circuit error that affects device functionality when programmed to a dual chamber mode with atrial-sensing.

Context

GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has had 29 other recalls since Dec. 19, 2017. Recent Medtronic recalls include CRTD Defibrillators with reduced energy output on May 10, 2023, and C304-HIS Device sterility risks on April 20, 2022.

How to tell if you have this one

Check if your device is a Medtronic dual chamber pacemaker (VDD) with model numbers RED01, REDR01, or REVDD01. The recall covers devices distributed between March 2017 and January 2019.

Brand
Medtronic
Product
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Wordlwide

Recall number	Product, codes & lots	Quantity
Z-0806-2019	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; 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	41802 units
Z-0807-2019	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; 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	9915 units
Z-0808-2019	Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01; RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01, GTIN: 00643169709003, All Serial Numbers (b) Model Number REDR01, GTIN: 00643169708990, 00643169969742, All Serial Numbers (c) Model Number REVDD01, GTIN: 00643169709010, 00643169969773, All Serial Numbers	7469 units
Z-0809-2019	Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1; SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers	59232 units
Z-0810-2019	Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1; 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	5392 units
Z-0811-2019	Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01; Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers	2040 units
Z-0812-2019	vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2; vitatron (implantable pulse generator): (a) A-series, Model Number: A30A1, GTIN 00643169709331; A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, GTIN 00643169709126, 00643169709140; E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, GTIN 00643169709249, 00643169709263; G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2, GTIN 00643169883017; Q70A2, GTIN 00643169882980; Q80A2, GTIN 00643169882997, All Serial Numbers	47086 units

Based on the official FDA remedy

What to do — step by step

Contact Medtronic
Reach out to Medtronic for specific guidance on your device model and whether a fix is needed.

How this recall unfolded

Recall timeline

FDA published this recall 34 days after the firm started it.

Jan 17, 2019Firm started the recall
Feb 14, 2019FDA classified it Class I
Feb 20, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using my pacemaker?

The recall does not require stopping use; it involves checking for circuit errors that may need correction.

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Link to this recall

<a href="https://govinfonow.com/recall/69097-medtronic-dual-chamber-pacemakers-circuit-error-risk-in-specific-models">Medtronic Dual Chamber Pacemakers: Circuit Error Risk in Specific Models (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0808-2019 (January 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0808-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.