Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
FDA Recall Z-1781-2017 · Posted 2017-03-23
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2016-12-13
Date Terminated2017-11-22
Product Quantity26 boxes of 5 (130 singles)
Reason for Recall
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
Firm Action
Customers were sent an Urgent Medical Device Removal letter, dated 12/5/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or [email protected]
Root Cause
Employee error
Distribution Pattern
AZ, FL, MO, NJ, NY, OH, PA, and TX.
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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