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

Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan… — recall Z-0807-2019

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

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0807-2019
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
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Wordlwide
Barcode (EAN/GTIN)
00643169882911
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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