Z-0599-03

Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M 218503M 210004M...

Name: Z-0599-03 Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M 218503M 210004M...
Creator: C. R.Bard, Inc./Electrophysiology Division
Published: 2003-01-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-01-08 / Terminated / root cause: packaging

FDA source

C. R.Bard, Inc./Electrophysiology Division began a recall of Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M 218503M 210004M 218504M 210005M 218505M 210006M 218506M 210007M 218507M... on 2003-01-08. The reason FDA records is "Sterile barrier maybe perforated compromising sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0599-03
Status: Terminated
Initiated: 2003-01-08
Posted: 2003-02-28
Terminated: 2012-05-03
Recalling firm: Boston Scientific Corporation
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
Reason for recall: Sterile barrier maybe perforated compromising sterility of the device
Root cause tag: packaging
FDA 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.
Distribution: Nationwide
Product codes and lots: All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)