—#139222

Product

AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

FDA product code: DXE — Catheter, Embolectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113363
Affected lot / code info: 161905

Why it was recalled

AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.

Timeline

Recall initiated: 2015-07-31
Posted by FDA: 2015-08-13
Terminated: 2016-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.