Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0808-2019 — Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01

U.S. FDA — Device Enforcement · United States · 2019-01-17 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0808-2019
Date of alert
2019-01-17
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00643169709003
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.