Myo/Wire 021-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841291100072), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Missing Information” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K803086); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2019Missing Information; Missing Information

  A CUSTOMER SENT AN INQUIRY ABOUT APPROPRIATE ATTACHMENT METHOD FOR THE M-21 LOOPED TEMPORARY PACING WIRE. THEY IDENTIFIED A DIFFERENCE IN THE DESCRIPTION OF ATTACHMENT ON THE A&E WEBSITE WHEN COMPARED TO THE IFU CONTENT: (WEBSITE DESCRIPTION) "M-21 STYLE, LOOP ELECTRODE: ONE-EIGHTH INCH DIAMETER BARE TEMPORARY CARDIAC PACING WIRE LOOP CAN BE SECURED ONTO THE MYOCARDIUM WITH A NON-TIED CONTINUOUS SUTURE THROUGH THE MYOCARDIUM AND WIRE LOOP. THE SUTURE WILL UNRAVEL DURING REMOVAL." (IFU DESCRIPTION) "ATRIAL LOOP TYPE SURFACE ELECTRODES ARE SECURED BY PLACING A SUTURE AROUND THE ELECTRODE NECK. SUTURE SHOULD BE SNUG, NOT TIGHT. DO NOT PLACE SUTURE THROUGH LOOP, THIS WILL PREVENT REMOVAL OF THE WIRE. LOOP WILL COMPRESS AND PASS THROUGH THE SUTURE WITH GENTLE TRACTION DURING REMOVAL." INVESTIGATION INTO THE INQUIRY DETERMINED THAT DURING AN IFU UPDATE (IFU REVISION 005) IN FEBRUARY 2018, ATTACHMENT INSTRUCTIONS FOR THE M-22 LOOPED ELECTRODE WERE INCLUDED IN THE IFU BUT NOT THE INSTRUCTIONS FOR THE M-21 LOOP. THE UPDATED INSTRUCTIONS DID NOT IDENTIFY THE LOOP TYPE. PRIOR TO THIS CHANGE, THE IFU HAD NO INSTRUCTIONS FOR ATTACHMENT SINCE THE PRODUCT IS STATED TO BE FOR USE BY TRAINED SURGEO

  Patient problems: No Code Available

  MAUDE report 8741742 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K803086. One submission often covers many models, so check the product and lot details in each record.

• Z-2993-2024 · Apr 8, 2024 · Open, Classified
  Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack
• Z-2991-2024 · Apr 8, 2024 · Open, Classified
  Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
• Z-2098-2019 · Jun 21, 2019 · Terminated
  A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopola