Recalls / —
—#139221
Product
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. 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
- K111182
- Affected lot / code info
- 162185 162318
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 #139221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.