AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, 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 Recall Z-2377-2015 · Posted 2015-08-13
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDXE
Date Initiated2015-07-31
Date Terminated2016-02-05
Product Quantitytotal of 9 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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