Bard® Heyman Follower 021314Recalls & reported problems
C. R. Bard, Inc. · Bard® Heyman Follower · Class 1
All models of Bard Heyman Follower (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741075612), received between May 15, 2018 and Oct 3, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jun 3, 2025Class IIOpen, Classified
Cather packaging may contain the incorrect French size.
Z-2075-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect Measurement2
- Dull, Blunt1
- Material Deformation1
Patient problems
- Injury1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2018Incorrect Measurement; Material Deformation; Incorrect Measurement
IT WAS REPORTED THAT THE HEYMANN FOLLOWER HAD A BLUNT TIP INSTEAD OF A TAPERED TIP.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7931025 ↗InjuryMay 15, 2018Incorrect Measurement; Incorrect Measurement; Dull, Blunt
IT WAS REPORTED THAT THE TIP WAS VERY BLUNT INSTEAD OF HAVING A SMOOTH TAPERED END. THIS ALLEGEDLY CAUSED SIGNIFICANT DAMAGE TO THE URETHRAL TISSUE. IT WAS LATER REPORTED BY DR. (B)(6) THAT THERE WAS NO CHANGE IN THE MEDICAL MANAGEMENT OF THE PATIENT WHO HAS A MORE TRAUMATIC DILATION (DAMAGE TO URETHRAL TISSUE) EXCEPT TO LEAVE THE POST-DILATION CATHETER IN LONGER.
Patient problems: Injury; Tissue Damage
MAUDE report 7516092 ↗
Other FILIFORM AND FILIFORM FOLLOWER devices
- Bard® Heyman Follower 021316C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall2 reports
- Bard® Heyman Follower 021312C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall2 reports
- Bard® Heyman Follower 021112C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall1 report
- Bard® Heyman Follower 021114C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall1 report
- Bard® Heyman Follower 021120C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall1 report
- Bard® Heyman Follower 021110C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall0 reports
- Bard® Heyman Follower 021100C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER5 reports
- Bard® Heyman Follower 021300C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page