—#74809

Product

Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080272
Affected lot / code info: Batch/lot #s 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295

Why it was recalled

Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: Worldwide Distribution --- USA including Puerto Rico and country of Panama

Timeline

Recall initiated: 2008-10-09
Posted by FDA: 2009-01-28
Terminated: 2009-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.