FDA Medical Device Recalls (openFDA)
C. R.Bard, Inc./Electrophysiology Division: Bard Stinger SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 210003SM 218503SM 210004SM 218504SM 210005SM 218505SM 210006SM 218506SM 210007SM 218507SM 210015SM 218516SM 210016SM 218518SM 210017SM 218519SM 210018SM 218520SM 210019SM 218521SM 210020SM 218523SM 210023SM 218524SM 210024SM 218525SM 210025SM 218526SM 210026SM 218527SM 210027SM 218528SM 210028SM 218529SM 210029SM 210030SM
- Recall number
- Z-0601-03
- Recalling firm
- C. R.Bard, Inc./Electrophysiology Division
- Product
- Bard Stinger SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 210003SM 218503SM 210004SM 218504SM 210005SM 218505SM 210006SM 218506SM 210007SM 218507SM 210015SM 218516SM 210016SM 218518SM 210017SM 218519SM 210018SM 218520SM 210019SM 218521SM 210020SM 218523SM 210023SM 218524SM 210024SM 218525SM 210025SM 218526SM 210026SM 218527SM 210027SM 218528SM 210028SM 218529SM 210029SM 210030SM
- 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