Bard® Heyman Follower 021300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741075582), received between Jul 5, 2018 and Nov 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT CUSTOMER WOULD LIKE TO KNOW IF THE BARD HEYMAN FOLLOWERS THEY HAD WERE EXPIRED. THEY ALSO COMPLAINED THAT EXPIRATION DATE WAS NOT ON THE OUTSIDE OF THE PACKAGING OF THE PARTICULAR LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732557 ↗
• MalfunctionJan 9, 2019Inadequate Instructions for Healthcare Professional; Manufacturing, Packaging or Shipping Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT A HEYMAN FOLLOWER LABELED WITH REF # 021310 WAS SHIPPED INSIDE OF A CASE LABELED REF # 021300. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8231523 ↗
• MalfunctionDec 3, 2018Component Missing

  IT WAS REPORTED THAT THE PATIENT ONLY RECEIVED THE 24FR DILATION CATHETER FROM A SET THAT SHOULD HAVE INCLUDED SIZES 10FR THROUGH 24FR. NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THAT THE 24FR CATHETER WAS USED; HOWEVER, THE MISSING SIZES WERE STILL NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8125578 ↗
• MalfunctionJul 5, 2018Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONLY A 24FR. WHEN THE ITEM SHOULD HAVE INCLUDED 7 ADDITIONAL SIZES IN THE SET OF 8. PER ADDITIONAL INFORMATION, IT WAS NOTED THAT THE PACKAGING DID NOT APPEAR TO BE FOR A SET OF 8.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664286 ↗