Bard® Heyman Follower 021312Recalls & 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 00801741075605), received between May 16, 2018 and Oct 2, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (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
- Dull, Blunt2
- Incorrect Measurement2
- Structural Problem1
Patient problems
- 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 2, 2018Incorrect Measurement; Dull, Blunt; Incorrect Measurement
IT WAS REPORTED THAT THE HEYMANN FOLLOWER HAD A BLUNT TIP INSTEAD OF A TAPERED TIP. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7925369 ↗InjuryMay 16, 2018Incorrect Measurement; Incorrect Measurement; Dull, Blunt; Structural Problem
IT WAS REPORTED THAT THE TIP WAS VERY BLUNT INSTEAD OF HAVING A SMOOTH TAPERED END. THE PATIENT ALLEGED SIGNIFICANT DAMAGE TO THE URETHRAL TISSUE. THERE WAS NO CHANGE IN THE MEDICAL MANAGEMENT OF A PATIENT THAT HAS A MORE TRAUMATIC DILATION (DAMAGE TO URETHRAL TISSUE), EXCEPT TO LEAVE THE POST-DILATION CATHETER IN LONGER.
Patient problems: Tissue Damage
MAUDE report 7519796 ↗
Other FILIFORM AND FILIFORM FOLLOWER devices
- Bard® Heyman Follower 021316C. R. Bard, Inc. · FILIFORM AND FILIFORM FOLLOWER1 recall2 reports
- Bard® Heyman Follower 021314C. 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.
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