—#125181

Product

Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080272
Affected lot / code info: Product number: H749364560, Catalog number: 36456; Lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014.

Why it was recalled

Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47215 Lakeview Blvd, Fremont, California 94538-6530

Distribution

Distribution pattern: US Nationwide Distribution and Mexico

Timeline

Recall initiated: 2014-01-06
Posted by FDA: 2014-01-30
Terminated: 2014-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.