ATAR D-IS1 2Pace ATAR D-IS1-2PaceRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672102074), received between Jun 16, 2017 and Jul 17, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K070926); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2017Connection Problem; Connection Problem

  ALTHOUGH REQUESTED, NO PATIENT INFORMATION WAS MADE AVAILABLE. THE REPORTED INCIDENT OCCURRED DURING A TEMPORARY PACER PROCEDURE. AS A RESULT OF THE REPORTED ISSUE, THEY HAD TO OPEN A PERMANENT GENERATOR TO PACE THE PATIENT. A DELAY IN CARE WAS REPORTED, HOWEVER IT IS NOTED THAT THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6720177 ↗
• MalfunctionJun 16, 2017Connection Problem; Connection Problem

  THE SET SCREW ON THE IS-1 RECEPTACLE PORTION OF THE EXTENSION DID NOT ENGAGE AS INTENDED. ON 5/8/2017 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER: WHAT IS THE OUTCOME OF THE PATIENT? HAD TO OPEN A PERMANENT GENERATOR TO PACE THE PATIENT. NO IMPACT TO THE PATIENT/ PATIENT STABLE? YES, DELAY IN CARE. WAS THERE ANY ADVERSE EFFECT TO THE PATIENT? NO. WAS THERE ANY EXTENDED HOSPITALIZATION? NO. WHAT PROCEDURE THE PRODUCT WAS USED FOR? TEMPORARY PACER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6649052 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070926. One submission often covers many models, so check the product and lot details in each record.

• Z-2733-2017 · Mar 31, 2017 · Terminated
  ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSAB
• Z-2340-2017 · Mar 31, 2017 · Terminated
  ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A