FDA Device Recall Z-0808-2019

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Mounds View, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01

Lot / serial / GTIN: 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

Quantity: 7469 units

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

Recall record

Recall number: Z-0808-2019
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Wordlwide
Recall initiated: 2019-01-17
Classified by FDA Center: 2019-02-14
FDA published: 2019-02-20
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Firm location: Mounds View, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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