Bard Heyman FollowerRecalls & reported problems across all models
C. R. Bard, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Bard Heyman Follower model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 16 models of Bard Heyman Follower by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between May 15, 2018 and Nov 20, 2024 — classified as 2 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (9 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Bard Heyman Follower recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 3, 2025Open, Classified
Cather packaging may contain the incorrect French size.
Z-2075-2025 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 3, 2025Open, Classified
Cather packaging may contain the incorrect French size.
Z-2074-2025 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
Most reported Bard Heyman Follower problems
Device problems
- Device Handling Problem9
- Fitting Problem9
- Incorrect Measurement8
- Component Missing5
- Dull, Blunt5
- Manufacturing, Packaging or Shipping Problem4
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient5
- No Patient Involvement4
- Tissue Damage2
- Injury1
Bard Heyman Follower models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Heyman Follower 021312FILIFORM AND FILIFORM FOLLOWER1 recall2 reports
- Bard® Heyman Follower 021314FILIFORM AND FILIFORM FOLLOWER1 recall2 reports
- Bard® Heyman Follower 021316FILIFORM AND FILIFORM FOLLOWER1 recall2 reports
- Bard® Heyman Follower 021112FILIFORM AND FILIFORM FOLLOWER1 recall1 report
- Bard® Heyman Follower 021114FILIFORM AND FILIFORM FOLLOWER1 recall1 report
- Bard® Heyman Follower 021120FILIFORM AND FILIFORM FOLLOWER1 recall1 report
- Bard® Heyman Follower 021110FILIFORM AND FILIFORM FOLLOWER1 recall0 reports
- Bard® Heyman Follower 021100FILIFORM AND FILIFORM FOLLOWER5 reports
- Bard® Heyman Follower 021300FILIFORM AND FILIFORM FOLLOWER4 reports
- Bard® Heyman Follower 021116FILIFORM AND FILIFORM FOLLOWER1 report
- Bard® Heyman Follower 021118FILIFORM AND FILIFORM FOLLOWER1 report
- Bard® Heyman Follower 021122FILIFORM AND FILIFORM FOLLOWER1 report
- Bard® Heyman Follower 021124FILIFORM AND FILIFORM FOLLOWER1 report
- Bard® Heyman Follower 021318FILIFORM AND FILIFORM FOLLOWER1 report
- Bard® Heyman Follower 021320FILIFORM AND FILIFORM FOLLOWER1 report
- Bard® Heyman Follower 021322FILIFORM AND FILIFORM FOLLOWER1 report
Recent Bard Heyman Follower adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134345 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134343 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114 , PCN 021112 , PCN 021116 , PCN 021118 , PCN 021120 , PCN 021122 , PCN 021124 , PCN 021316 , PCN 021100 , PCN 021905 , PCN 021906 , PCN 022105). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUL2023, IT WAS REPORTED THAT CUSTOMER THOUGHT THERE MIGHT HAVE BEEN SOME CONFUSION WITH THIS. THERE WAS NOT ISSUE WITH THE PRODUCT ITSELF AND THEY HAD MISMATCHED FOLLOWERS AND FILIFORM ON HAND WHICH CAUSED AN ISSUE, ON THEIR END THEY FIGURED OUT THE ISSUE AND JUST HAD THE WRONG PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134339 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUL2023, IT WAS REPORTED THAT CUSTOMER THOUGHT THERE MIGHT HAVE BEEN SOME CONFUSION WITH THIS. THERE WAS NOT ISSUE WITH THE PRODUCT ITSELF AND THEY HAD MISMATCHED FOLLOWERS AND FILIFORM ON HAND WHICH CAUSED AN ISSUE, ON THEIR END THEY FIGURED OUT THE ISSUE AND JUST HAD THE WRONG PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134338 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114 , PCN 021112 , PCN 021116 , PCN 021118 , PCN 021120, PCN 021122, PCN 021124 , PCN 021316 , PCN 021100, PCN 021905 , PCN 021906 , PCN 022105). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUL2023, IT WAS REPORTED THAT CUSTOMER THOUGHT THERE MIGHT HAVE BEEN SOME CONFUSION WITH THIS. THERE WAS NOT ISSUE WITH THE PRODUCT ITSELF AND THEY HAD MISMATCHED FOLLOWERS AND FILIFORM ON HAND WHICH CAUSED AN ISSUE, ON THEIR END THEY FIGURED OUT THE ISSUE AND JUST HAD THE WRONG PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134337 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134334 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134060 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUL2023, IT WAS REPORTED THAT CUSTOMER THOUGHT THERE MIGHT HAVE BEEN SOME CONFUSION WITH THIS. THERE WAS NOT ISSUE WITH THE PRODUCT ITSELF AND THEY HAD MISMATCHED FOLLOWERS AND FILIFORM ON HAND WHICH CAUSED AN ISSUE, ON THEIR END THEY FIGURED OUT THE ISSUE AND JUST HAD THE WRONG PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134057 ↗MalfunctionJun 15, 2023Fitting Problem; Device Handling Problem; Fitting Problem; Device Handling Problem
T WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105). AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUL2023, IT WAS REPORTED THAT CUSTOMER THOUGHT THERE MIGHT HAVE BEEN SOME CONFUSION WITH THIS. THERE WAS NOT ISSUE WITH THE PRODUCT ITSELF AND THEY HAD MISMATCHED FOLLOWERS AND FILIFORM ON HAND WHICH CAUSED AN ISSUE, ON THEIR END THEY FIGURED OUT THE ISSUE AND JUST HAD THE WRONG PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17133947 ↗MalfunctionJul 19, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THERE WAS MISSING PRODUCT WITHIN THE PACKAGING. CUSTOMER ONLY RECEIVED ONE SET OF 10 FRENCH FOLLOWERS IN THEIR SHIPMENT WHEN IT SHOULD INCLUDE VARIOUS SIZES UP TO 24 FRENCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15051944 ↗MalfunctionJan 18, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE PATIENT ORDERED 2 SETS OF FOLLOWERS AND RECEIVED ONLY 1 EACH OF 18FR AND 20FR. THERE SHOULD BE EIGHT IN EACH SET AND 1 EACH OF 10FR-24FR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13286588 ↗MalfunctionAug 22, 2019Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing
IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INCOMPLETE SET. REPORTEDLY ONLY THE 10FR, 12FR AND 24FR WERE RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8922569 ↗MalfunctionAug 22, 2019Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing
IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INCOMPLETE SET. REPORTEDLY ONLY THE 10FR, 12FR AND 24FR WERE RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8920613 ↗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 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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