FDA Medical Device Recalls (openFDA)
C. R.Bard, Inc./Electrophysiology Division: Bard Stinger S Ablation Catheter: Item Numbers 210001S 218501S 6210015S 210002S 218502S 6210016S 210003S 218503S 6210017S 210004S 218504S 6210018S 210005S 218505S 6210019S 210006S 218506S 6210020S 210007S 218507S 210015S 218516S 210016S 218518S 210017S 218519S 210018S 218520S 210019S 218521S 210020S 218523S 210023S 218524S 210024S 218525S 210025S 218526S 210026S 218527S 210027S 218528S 210028S 218529S 210029S 210030S
- Recall number
- Z-0600-03
- Recalling firm
- C. R.Bard, Inc./Electrophysiology Division
- Product
- Bard Stinger S Ablation Catheter: Item Numbers 210001S 218501S 6210015S 210002S 218502S 6210016S 210003S 218503S 6210017S 210004S 218504S 6210018S 210005S 218505S 6210019S 210006S 218506S 6210020S 210007S 218507S 210015S 218516S 210016S 218518S 210017S 218519S 210018S 218520S 210019S 218521S 210020S 218523S 210023S 218524S 210024S 218525S 210025S 218526S 210026S 218527S 210027S 218528S 210028S 218529S 210029S 210030S
- Status
- Terminated
- Initiated
- 2003-01-08
- Posted
- 2003-02-28
- Terminated
- 2012-05-03
- Reason
- Sterile barrier maybe perforated compromising sterility of the device
- Root cause
- Packaging process control
- Action
- Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000120754
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28