Z-1319-2012

Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist...

Name: Z-1319-2012 Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist...
Creator: Boston Scientific Corporation
Published: 2012-03-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2012-03-02 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick... on 2012-03-02. The reason FDA records is "Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1319-2012
Status: Terminated
Initiated: 2012-03-02
Posted: 2012-03-28
Terminated: 2012-11-14
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Boston Scientific sent a Urgent Medical Device Recall letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed to cease use, quarantine and return unused product with directions to forward the notification to the hospital level. Customers were directed to fill out the Reply Verification Tracking Form and fax to 5086835578, for reimbursement. Returned goods are to be sent to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. For further questions please call (508) 683-4678.
Quantity in commerce: 682 (1555 used)
Distribution: USA (nationwide) and the countries of Canada, Columbia, Viet Nam, Germany, France, Great Britain, Italy, Jordan, Kuwait, Netherlands Pakistan, Portugal, S. Arabia, Slovakia, Spain, Sweden and Tunisia.
Product codes and lots: Soloist Single Needle M001262500 Reference Inner 14386589, 14435130, 14578709, 14629530, 14715963, Electrode -18cm (outer pouch Information) 14722621, 14776399, 14805361 box)

Product code GEI

K053128Class IISoloist Single Needle ElectrodeelectrodeBoston Scientific Corp / cleared 2005-11-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)