FDA Medical Device Recalls (openFDA)
C. R.Bard, Inc./Electrophysiology Division: Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M 218503M 210004M 218504M 210005M 218505M 210006M 218506M 210007M 218507M 210015M 218516M 210016M 218518M 210017M 218519M 210018M 218520M 210019M 218521M 210020M 218523M 210023M 218524M 210024M 218525M 210025M 218526M 210026M 218527M 210027M 218528M 210028M 218529M 210029M 210030M
- Recall number
- Z-0599-03
- Recalling firm
- C. R.Bard, Inc./Electrophysiology Division
- Product
- Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M 218503M 210004M 218504M 210005M 218505M 210006M 218506M 210007M 218507M 210015M 218516M 210016M 218518M 210017M 218519M 210018M 218520M 210019M 218521M 210020M 218523M 210023M 218524M 210024M 218525M 210025M 218526M 210026M 218527M 210027M 218528M 210028M 218529M 210029M 210030M
- 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