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 Recall Z-0837-2009 · Posted 2009-01-28
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeITX
Date Initiated2008-10-09
Date Terminated2009-07-27
Product Quantity1033 units
Reason for Recall
Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution --- USA including Puerto Rico and country of Panama
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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